China

Medical Devices

In China, Medical Devices are regulated by The National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly the China Food and Drug Administration or CFDA).Due to the rise of complex technologies and constant change of the regulatory environment, regulatory affairs professionals in the Medical Device Industry are facing many challenges  to keep up with the new technologies and new National Medical Product Administration (NMPA) regulations and guidelines, to be able to define the correct pathway for their products development and registration with the  NMPA.

Global Regulatory Partners Inc.  (GRP), has offices in Shanghai and Beijing with teams of regulatory affairs, clinical, quality and pharmacovigilance experts who can collect the regularly intelligence develop the appropriate regulatory strategy and register successfully your medical device or IVD with the NMPA.

Related Links:

NMPA. Medical Devices.http://english.nmpa.gov.cn/medicaldevices.html

Provision for Medical Device Registration. (2014).http://english.nmpa.gov.cn/2019-07/25/c_390617.htm

NMPA Main Responsibilities. http://english.nmpa.gov.cn/2019-07/18/c_377587.htm

Authorized local agent

National Medical Product Administration (NMPA) requires any foreign manufacturer who intends to register and sell its products in the People’s Republic of China to retain a local agent with a physical address in China.

In China, GRP China is licensed by NPMA to act as your Local Agent. in China.

GRP- China Local Agent Services:

  • Communicate with the NMPA
  • Assist with NMPA inspection
  • Adverse Effect Reporting
  • Establishment registration and product listing
  • Product registration
  • Organize and support NMPA consultation meetings.
  • Support importation process
  • Provide support and manage product local testing
  • Manage distributors
  • License Renewal

Regulatory intelligence

Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization.

Due to the continuously evolving nature of the Regulatory environment, it is becoming more challenging for regulatory professionals to stay up-to-date and collect the appropriate RI related to their product in a timely manner.

At Global Regulatory Partners Inc., a team of professionals can provide you with tailored Regulatory Intelligence that includes the latest regulatory information and our recommendations for the most appropriate and effective strategy to address your particular- needs.

Regulatory Strategy

The regulatory process from product design to market entry for a new medical device or IVD is oftentimes complicated and unclear. Most of the Chinese regulations are in Chinese and are changing continuously.

GRP Inc. RA team stays current with the latest legislation, regulatory requirements and interpretations and industry initiatives in China. GRP’s team makes sure that its clients are kept informed of changes in the regulatory environment that may impact their regulatory and business strategies in China.

Our regulatory team in China has the expertise in developing effective and tailored regulatory strategies for medical device companies that helps them get their products successfully registered in China, in timely manner and with minimum risk.

Regulatory Affairs

Global regulatory Partner, Inc., provides a full regulatory affairs service from product concept throughout product development till product registration.

Our regulatory affairs services include regulatory intelligence, regulatory strategy, regulatory operations, and publishing; product registration, registration amendments; consulting meetings with regulatory authorities.

Our Regulatory affairs teams help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in order to successfully register and commercialize their products in new markets and maximize the value of their assets.

Product registration

Although China’s medical regulatory bodies are becoming more harmonized with international standards, the Chinese registration process still poses significant difficulties for Western medical device and pharmaceutical firms.

Device should be approved in original country before it is registered in China. Every medical device should be registered with NMPA for getting market access in China. If you require assistance with obtaining approval for your medical device in China, at Global regulatory Partners Inc., (GRP) we can help you prepare the necessary documents and register your product with the Chinese regulatory authorities.

Classification of medical devices in China:

Device Class Description
Class I The safety and effectiveness of the device can be ensured through routine administration.
Class II Further control is required to ensure the safety and effectiveness of the device.
Class III The device is implanted into the human body; used for life support or sustenance; or pose potential risk to the human body, and thus must be strictly controlled in respect to safety and effectiveness.

Health authority consultation

Consultation meetings can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan.

GRP regulatory affairs team supports includes: writing, preparation and submission of the meeting package to the health authority, prepare the questions to health authority based on the status of your product’s development and future plan, provide support during the meeting, write the meeting minutes and develop the appropriate action plan after the consultation meeting.  GRP regulatory affairs team has organized and supported over 100 consultation meeting with different health authorities in different markets.

Medical writing

Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products. As Regulatory authorities expect precise, clear and well-written documents, any bad writing can raise health authorities queries and consequently delay product approval. Global Regulatory Partners, Inc., has a team of professional medical writers who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules.

Clinical

Medical Device clinical trials in China must comply with China’s GCP requirements. It is important to determine if the device requires the clinical trials. This can be decided based on the classification of the device.

As is the case in many countries around the world, a local clinical trial is almost always required for the registration of drugs in China. Since drug registration in China follows global International Conference on Harmonization (ICH) guidelines, data requirements in China are like those in the United States and other developed countries. However, companies may encounter difficulties if they want to keep sensitive data confidential from copying competitors.

In some cases, as an alternative to local clinical studies, a bioequivalence (BE) study will be required instead. The BE study will test similarities between two drugs believed to have the same active ingredients and use.

The filing process for clinical trials in China begins with submitting a Clinical Trial Application (CTA) dossier to the NMPA. The Center for Drug Evaluation (CDE) reviews the submission dossier, test report, and verified specification, and requests a panel meeting if any concerns or questions are raised. The CDE may issue supplementary requests if any additional documents are needed from the applicant. The National Institute of Food and Drug Control (NIFDC) tests and analyzes the quality of the drug samples, while the Center of Food and Drug Inspection (CFDI) inspects sponsors and manufacturing sites.

After the CDE’s review, a recommendation on whether to grant the applicant a Clinical Trial Permit (CTP) is submitted for confirmation to the NMPA. The CTP approval requires an extensive length of time—about 18 months after the initial CTA dossier is submitted to the NMPA. The NMPA prioritizes which clinical trial proposals to review first according to the product’s level of importance. Drugs that aim to cure serious diseases, such as AIDS and cancer, are normally fast tracked to get clinical trial approval.

After obtaining a CTP, the company is free to initiate clinical trials at any approved site in China, as long as they follow Good Clinical Practices (GCP) throughout the clinical trials.

The NMPA’s Drug Regulatory Department oversees local clinical trials and affirms compliance with GCP. Generally, clinical trials in China involve four phases:

  • Phase I – an initial review of the drug’s safety to humans
  • Phase II – an evaluation of the effectiveness of the drug
  • Phase III – a confirmation for the effectiveness of the drug
  • Phase IV – a post-marketing study

The clinical trial’s sample size must meet statistical requirements by satisfying the minimum number of subjects outlined by the NMPA.  If the institution is unable to reach the minimum sample size because of the rarity of a disease, the institution should appeal to the appropriate provincial-level FDA (PFDA) to reduce the sample size.

The trial must be carried out by an organization certified to conduct drug clinical trials, using drugs from manufacturing facilities that follow Good Manufacturing Practices (GMP).

If there is a serious adverse event, investigators must notify the PFDA and applicants within 24 hours, and the ethics committee thereafter. If an event is serious, the PFDA may suspend or terminate the trial. A trial may also be terminated due to fraud, ethical concerns, and failure to report adverse events.

Quality

The NMPA has issued various regulations to strengthen management and organization at medical device manufacturing sites. This includes implementing Good Manufacturing Practice (GMP) standards for all medical devices, a more stringent adverse events and recalls system, additional on-site inspections, and other new industry standards. In addition to the NMPA, the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) also carries out safety, certification, and inspection of certain medical devices to ensure adherence to quality standards.

However, despite the improving standards and implementation of GMP regulations for medical devices in China, there are still many scandals regarding defective products due to poor quality systems. Foreign companies will need to conduct audits in order to ensure that their operations or partners in China are performing according to expected standards.

There are two types of on-site audits that are required in China: a one-time quality management system (QMS) audit for registration that domestic and foreign manufacturers must complete, and a GMP audit for a manufacturing license after registration that local manufacturers must complete annually. Requirements for these audits include an on-site audit checklist as well as multiple company meetings.

CHALLENGES TO MEETING GMP STANDARDS IN CHINA

  • In some factories in China, there are no organized or centralized quality manuals that employees can readily access. As a result, quality control in these factories may be minimal. Thorough audits can help locate the areas that are deficient and update the quality systems to meet Western standards.
  • There may be poor document control and reporting inconsistency.
  • if procedures change, the changes are usually not documented. When a device is reported as having failed, some factories do not investigate or report the adverse events. Having the factory audited can help identify post-market surveillance issues and set up systems for reporting adverse events.
  • Even after a factory is GMP compliant and a good quality system is set in place, problems will still arise if employees are not invested in the process.
  • It is essential that those employed by the medical device factory upkeep the maintenance required to guarantee an effective quality system. Many do not understand (or care about) the ramifications of poor-quality control or intellectual property theft.

Pharmaceuticals

Global Regulatory Partners, Inc. (GRP), provides end-to-end regulatory affairs services that allow our clients register their drug, biologic or generic products in different countries at record time. Our regulatory services include regulatory intelligence, regulatory strategy, regulatory operations and publishing, products’ registration and products’ life cycle management.

Our local offices in Shanghai and Beijing in can act as your local authorized agent in different countries and our regulatory team can support your company throughout the whole products’ lifecycle, ensuring compliance with local regulations and providing vital scientific and strategic advice from products’ development till commercialization.

Related links:

Provision for Drug Registration. http://subsites.chinadaily.com.cn/nmpa/2019-07/25/c_390615.htm

 

Authorized local agent

National Medical Product Administration (NMPA) requires any foreign manufacturer who intends to register and sell its products in the People’s Republic of China to retain a local agent with a physical address in China.

 GRP  is licensed by NPMA to act as your Local Agent in China.

GRP Local Agent Services in China:

  • Communicate with the NMPA
  • Assist with NMPA inspection
  • Adverse Effect Reporting
  • Establishment registration and product listing
  • Product registration
  • Organize and support NMPA consultation meetings.
  • Support importation process
  • Provide support and manage product local testing
  • Manage distributors
  • License Renewal

Regulatory intelligence

Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization.

Due to the continuously evolving nature of the Regulatory environment, it is becoming more challenging for regulatory professionals to stay up-to-date and collect the appropriate RI related to their product in a timely manner.

Global Regulatory Partners Inc., a team of professionals can provide you with tailored Regulatory Intelligence that includes the latest regulatory information and recommendations for the commercialization of your Pharmaceutical or Biologic products in China’s market.  For more information contact us or check out our resource center.

Regulatory Strategy

The regulatory process from product design to market entry for a new drug is oftentimes complicated and unclear. Most of the NMPA regulations are in Chinese and are changing continuously. Our regulatory team stays current with the latest legislation, regulatory requirements and interpretations and industry initiatives in China.

Our regulatory team in China makes sure that our clients are kept informed of all changes that occur at the NMPA that may impact their regulatory and business strategies in china.

Our regulatory team in China has many years of experience developing effective and tailored regulatory strategies for pharmaceutical companies that help them register successfully their drugs in China and with minimum risk.

Regulatory Affairs

Global regulatory Partner, Inc., (GRP) provides a full regulatory affairs services to Pharmaceutical and Biologic companies globally, from their products’ development and registration till commercialization.

GRP regulatory affairs services include regulatory intelligence, regulatory strategy, regulatory operations and publishing, product’s registration, products’ life cycle management and maintenance.

Regulatory Operations

Global Regulatory Partners Inc., (GRP) offers full electronic submission services from eCTD preparation, publishing and submission activities in China.  GRP’s dedicated team of experts ensures the quality and validity of the dossier submissions in accordance to the technicalities of regional eCTD requirements.

Global Regulatory Partners Inc. (GRP) Regulatory operation services include consulting services, planning and assembly of submissions, document creation and approval, e-Submission roadmap compliance, publishing, viewing and navigation, archiving, submission process optimization, tracking and lifecycle management.  GRP remains in compliance by implementation of Regulatory Information Management (RIM) with XEVMPD and IDMP requirements.  GRP will facilitate and coordinated management of all paper and electronic submissions, both eCTD and non-eCTD electronic submissions, and ensure timely submissions.

Product registration

The process of drugs registrations in China depends on the category they belong to. NMPA classifies drugs is three categories:

  • Chemical
  • Biological  
  • Traditional Chinese Medicine.

All drugs and drug substances (APIs) manufactured outside China must be registered via the imported drug application. Foreign-made APIs need to undergo a process like drug registration. Even if a product is approved elsewhere, the NMPA will most likely still require the foreign manufacturer to conduct at least some clinical testing in China before the drug is approved in China.

Global Regulatory Partners can help your medical company with all aspects of pharmaceutical product or API registration in China. For more information for your product’s registration pathway in China visit our White Papers or Contact us.

Related Links:

Provision for  Drug Registration.http://subsites.chinadaily.com.cn/nmpa/2019-07/25/c_390615.htm

Good Manufacturing Purpose for Drugs. (2010). http://subsites.chinadaily.com.cn/nmpa/2019-07/25/c_390613.htm

 

Medical writing

Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products. As Regulatory authorities expect precise, clear and well-written documents, any bad writing or badly translated documents can raise  NMPA  authorities queries and consequently delay product approval. Global Regulatory Partners, Inc., has a team of professional medical writers who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules.

Health Authority Consultation

Consultation meetings can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan.

GRP regulatory affairs team supports includes: writing , preparation and submission of the meeting package to the health authority, prepare the questions to health authority based on the status of your product’s development and future plan, provide support during the meeting, write the meeting minutes and develop the appropriate action plan after the consultation meeting. GRP regulatory affairs team has organized and supported over 100 consultation meeting with different health authorities in different markets. For more information on health consultations check out our resource center or contact us.

Clinical

As is the case in many countries around the world, a local clinical trial is almost always required for the registration of drugs in China. Since drug registration in China follows global International Conference on Harmonization (ICH) guidelines, data requirements in China are like those in the United States and other developed countries. However, companies may encounter difficulties if they want to keep sensitive data confidential from copying competitors.

In some cases, as an alternative to local clinical studies, a bioequivalence (BE) study will be required instead. The BE study will test similarities between two drugs believed to have the same active ingredients and use.

The filing process for clinical trials in China begins with submitting a Clinical Trial Application (CTA) dossier to the CFDA. The Center for Drug Evaluation (CDE) reviews the submission dossier, test report, and verified specification, and requests a panel meeting if any concerns or questions are raised. The CDE may issue supplementary requests if any additional documents are needed from the applicant. The National Institute of Food and Drug Control (NIFDC) tests and analyzes the quality of the drug samples, while the Center of Food and Drug Inspection (CFDI) inspects sponsors and manufacturing sites.

After the CDE’s review, a recommendation on whether to grant the applicant a Clinical Trial Permit (CTP) is submitted for confirmation to the NMPA. The CTP approval requires an extensive length of time—about 18 months after the initial CTA dossier is submitted to the NMPA. The NMPA prioritizes which clinical trial proposals to review first according to the product’s level of importance. Drugs that aim to cure serious diseases, such as AIDS and cancer, are normally fast tracked to get clinical trial approval.

After obtaining a CTP, the company is free to initiate clinical trials at any approved site in China, as long as they follow Good Clinical Practices (GCP) throughout the clinical trials.

The NMPA’s Drug Regulatory Department oversees local clinical trials and affirms compliance with GCP. Generally, clinical trials in China involve four phases:

  • Phase I – an initial review of the drug’s safety to humans
  • Phase II – an evaluation of the effectiveness of the drug
  • Phase III – a confirmation for the effectiveness of the drug
  • Phase IV – a post-marketing study

The clinical trial’s sample size must meet statistical requirements by satisfying the minimum number of subjects outlined by the NMPA. If the institution is unable to reach the minimum sample size because of the rarity of a disease, the institution should appeal to the appropriate provincial-level FDA (PFDA) to reduce the sample size.

The trial must be carried out by an organization certified to conduct drug clinical trials, using drugs from manufacturing facilities that follow Good Manufacturing Practices (GMP).

If there is a serious adverse event, investigators must notify the PFDA and applicants within 24 hours, and the ethics committee thereafter. If an event is serious, the PFDA may suspend or terminate the trial. A trial may also be terminated due to fraud, ethical concerns, and failure to report adverse events.

Related Links:

Provision for Drug Registration. Chapter III. Drug Clinical Trials. http://subsites.chinadaily.com.cn/nmpa/2019-07/25/c_390615.htm

 

Cosmetics

In China Cosmetics are regulated by the National Medical Products Administration (NMPA) under the Regulations Technical Safety Standard for Cosmetics of 2015. The regulation defines cosmetics as: “Products that can be spread on the outer surface of human body (e.g. skin, hairs, nails. lips etc.), the teeth and oral mucosa for the purpose of cleaning, protecting, beautifying, deodorizing and keeping in good condition, by way of smearing, spraying or other similar means”. Cosmetic products are divided into two categories: Non-Special Use Cosmetics (Non-SUC) (such as hair care, skin care, nail products, and fragrances), and Special-Use Cosmetics (SUC) (such as hair regrowth products, deodorants and sunscreens). Cosmetics require different pre-market applications depending on their category. Foreign manufacturers that want to import cosmetics (SUC and Non-SUC) products into China need to assign an Authorized Local Agent who will handle their products’ registration in the country.

Global Regulatory Partners Inc., affiliate in China (GRP- China) can act as your local representative in China and can help you find the right regulatory strategy to commercialize your Cosmetics in China. GRP-China team of professionals in Beijing and Shanghai offices, can register your cosmetics in China, review the formulation and labeling of your Cosmetics in line with NMPA regulations.

Authorized local agent

National Medical Product Administration (NMPA) requires any foreign manufacturer who intends to register and sell its products in the People’s Republic of China to retain a local agent with a physical address in China.

Global regulatory Partners, Inc. (GRP) has local offices in Beijing and Shanghai that are licensed by local authorities to act as your local agent and can help you register and import your cosmetics (SUC and Non-SUC) products into China.

GRP- China Cosmetic Services:

  • Authorized local Agent
  • Regulatory intelligence
  • Regulatory Strategy
  • Regulatory affairs
  • Product Registration
  • Cosmetic packaging and labeling review
  • Product classification & Formulation Review

Regulatory intelligence

Cosmetics are regulated differently from country to country. While some countries require registration of cosmetic products others only require a notification. GRP experts can collect the regulatory and other important requirements applicable to your product such as: registration dossier, claims, prohibited list of ingredients, importation regulations, specification of ingredients and labeling requirements that are needed to establish the correct strategy for your product commercialization in a market. For more information on Cosmetic Regulatory Intelligence in China check out our Resource Center.

Regulatory Strategy

Developing the right regulatory strategy for your products is crucial for successful product development, registration, and commercialization in China. Global Regulatory Partners, Inc., (GRP) team has expertise in developing the appropriate and effective regulatory strategy for different types of products and for different markets. Our strategy will help you meet your business objectives and goals and reduce your risk of failure. In developing the regulatory strategy, our team takes into consideration different factors such as information on your products and similar products on the market, your product development status and milestones, your business goals and timelines, the regulatory requirements related to your product, cost, and risk assessment. With a global presence and a local team of experts, GRP regulatory strategy will give you confidence in the forecast of key milestones, a list of the necessary documentation needed for product development and registration, timelines and cost of the different activities, and action plan to meet your milestones.

Regulatory Affairs

Global regulatory Partner, Inc. provides a full regulatory affairs service from product concept throughout product development till product registration. Our regulatory affairs services include regulatory intelligence, regulatory strategy, regulatory operations, and publishing; product registration, registration amendments; consulting meetings with regulatory authorities. Our Regulatory affairs teams help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in order to successfully register and commercialize their products in new markets and maximize the value of their assets.

Cosmetic packaging and labeling review

Global regulatory Partners, Inc., provides end-to-end cosmetics packaging and labeling services to enable manufacturers effectively navigate region-specific regulations, manufacture and sale compliant products. GRP’s services include cosmetic packaging and labeling review to ensure that their content is in compliant with local and /or regional requirements and the products can be used safely by consumers.

GRP Inc. can review your products and make sure they comply with the NMPA regulations for cosmetics under the Technical Safety Standard for Cosmetics of 2015.

Product classification & Formulation Review

Global Regulatory Partners Inc. provides a comprehensive range of Regulatory Services related to the analysis of the list of cosmetic and PCP ingredients, the review of their formulation and labeling. GRP Inc. can review your products and make sure they comply with the NMPA regulations for cosmetics under the Technical Safety Standard for Cosmetics of 2015.

Nutraceuticals

There are currently two kinds of dietary supplements in China: functional food and nutrition supplements. Functional food must be registered before entering China’s market. As it can have different functions, such as enhancing immunity, helping the protection against radiation hazards, improving sleeping quality, increasing bone density, acting antioxidants, and improving memory. Nutrition supplements are generally used to supplement and correct deficiencies with the intake of certain vitamins and or minerals.

Global Regulatory Partners, Inc. (GRP) has a team of experts in China who can help Nutraceutical and food supplements companies in China during their products’ development. The team reviews the list of ingredients to make sure that they are safe for consumers and are within the daily dose limits allowed by local regulations. The team also reviews and validate the content of the products labeling and packaging and makes sure that nutrient content claims and health claims made by the manufacturer are validated and supported by scientific data before any products’ commercialization.

Authorized local agent

National Medical Product Administration (NMPA) requires any foreign manufacturer who intends to register and sell its products in the People’s Republic of China to retain a local agent with a physical address in China.

Global regulatory Partners, Inc. (GRP) has local offices in Beijing and Shanghai that are licensed by local authorities to act as your local agent and can help you register and commercialize your nutraceuticals (Functional food and nutrition supplements) in China.

GRP- China Nutraceutical Services:

  • Authorized local agent
  • Regulatory intelligence
  • Regulatory strategy
  • Regulatory affairs
  • Product Registration
  • Verification of Nutrient Content Claims
  • Verification of Health Claims

Regulatory Affairs

Global regulatory Partner, Inc., (GRP) provides a full regulatory affairs service from product concept throughout product development till product registration. Our regulatory affairs services include regulatory intelligence, regulatory strategy, product registration, product formulation and labelling review.

GRP team provides support to Nutraceutical companies during their products’ development. The team reviews the list of ingredients to make sure that they are safe for consumers, reviews and validates the nutrient content claims and health claims before products’ commercialization.

Regulatory intelligence

Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization.

Due to the continuously evolving nature of the Regulatory environment, it is becoming more challenging for regulatory professionals to stay up-to-date and collect the appropriate RI related to their product in a timely manner.

At Global Regulatory Partners Inc., a team of professionals can provide you with tailored Regulatory Intelligence that includes the latest regulatory information and recommendations for the commercialization of your Nutraceuticals in different markets.

Regulatory Strategy

Developing the right regulatory strategy for your Nutraceuticals in different markets is crucial for successful product development, registration, and commercialization. Global Regulatory Partners, Inc., (GRP) team has expertise in developing the appropriate and effective regulatory strategy for different types of Nutraceuticals for different markets. GRP strategy will help you meet your business objectives and goals and reduce your risk of failure.

In developing the regulatory strategy, our team takes into consideration different factors, such as information on your products and similar products on the market, your product development status and milestones, your business goals, your timelines, the regulatory requirements related to your product, cost, and risks.

With a global presence and a local team of experts, GRP regulatory strategy will help forecast your Nutraceutical launch and commercialization with confidence.

Verification of Nutrient Content Claims

Nutritional claims are those that state, suggest or imply that a food has some particular- beneficial nutritional properties. This information helps consumers to take an informed decision about whether to purchase and consume the product or not.

Nutritional labels and packaging should include information on energy, calories, fats, sugars, proteins and salts. It is important that all this information is accurate and correct, as all nutritional details must comply with the Regulations.

In addition, the regulations have certain rules governing the provision of voluntary nutrition information, particularly for the front of pack labeling, the nutritional labeling of non-pre-packaged foods and the energy labeling of alcoholic drinks. Some nutrients are now prohibited to be declared. A nutrient content claim expressly or by implication characterizes the level of a nutrient in a dietary supplement.

Verification of Health Claims

Health claims are directed to the general population or designated subgroups (e.g., the elderly) and are intended to assist the consumer in maintaining healthful dietary practices.

GRP team has the expertise in reviewing and validating the health claims that you are making for you nutraceutical products or dietary supplements to make sure that they are supported by scientific data, are accurate and can be accepted by different health authorities.

 

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