Overview:
RDC 31/2014 is essential for ensuring that specific medicines available on the market are safe and effective for consumers. It ensures that these products, even if they have peculiar characteristics, meet strict technical requirements before being made available to the population. This DRC also deals with clone medicines, what is required for registration with ANVISA and how to follow the steps correctly
Introduction:
A clone medicine is one that has the same composition, concentration, pharmaceutical form, route of administration, posology and therapeutic indication as a medicine already registered and marketed in Brazil. It is an identical copy of a reference medicine, but it can be manufactured by a different laboratory, as long as its efficacy and safety are proven to be equivalent to the original.
Registering a clone drug with ANVISA is a rigorous process that requires attention to detail and compliance with all regulatory requirements. However, by following the steps correctly, the company can obtain registration efficiently and guarantee the entry of a safe and effective product onto the market. Complying with these steps also contributes to consumer confidence and the company’s credibility in the pharmaceutical sector.
Why Register a Clone Drug
Registering a clone drug offers several advantages, such as reducing development costs, since efficacy and safety have already been established by the reference drug. It also increases patient access to quality treatments and can stimulate competition in the market, which can result in lower prices.
Requirements for Registering a Clone Drug with ANVISA:
1. Legal requirements and documentation
Before starting the registration process, it is essential to ensure that the company is legally established and has authorization to operate with ANVISA. In addition, it is necessary to gather the basic documentation, which includes:
- A certified copy of the company’s articles of association or bylaws.
- Company Operating Authorization (AFE).
- Good Manufacturing Practices Certificate (CBPF).
2. Technical Dossier
- The next step is to draw up the Technical Dossier for the Clone Drug, which should include detailed information about the product, such as:
- Reference Drug Data: Name of the drug, manufacturer, registration number and other relevant details.
- Production and Quality Control Report: Proof that the clone medicine is identical to the reference medicine, containing all the quality tests carried out.
- Bioequivalence studies: Although it is a clone, studies must be submitted to prove that the medicine has the same therapeutic performance as the reference medicine.
- Labels and Packaging: Proposals for labelling and packaging material that comply with the standards laid down by ANVISA.
3. Electronic submission of the dossier
- With all the documents ready, the next step is to submit the technical dossier to ANVISA via the agency’s electronic system, known as SINE (ANVISA Information System). It is important to make sure that all the files are in the required format and duly digitally signed.
4. Analysis and Evaluation by ANVISA
- After submission, ANVISA will carry out a technical and regulatory analysis of the dossier. During this phase, the agency may request additional information or clarifications, known as technical requirements. The company must respond to these requirements within the stipulated timeframe to avoid delays in the registration process.
5. Registration Approval and Publication
- If all the steps are successfully completed, ANVISA will approve the registration of the clone drug. The decision will be published in the Federal Official Gazette (DOU), and the medicine will be ready to be marketed in Brazil.
6. Post-registration and monitoring
- After registration, the clone drug will be subject to continuous monitoring, including pharmacovigilance and good manufacturing practice inspections. The company must ensure that the product continues to meet the quality and safety standards established by ANVISA.
Considerations
Registering a clone drug with ANVISA is a rigorous process that requires attention to detail and compliance with all regulatory requirements. However, by following the steps correctly, the company can obtain registration efficiently and guarantee the entry of a safe and effective product onto the market. Complying with these steps also contributes to consumer confidence and the company’s credibility in the pharmaceutical sector.
Conclusion
If you are considering registering a clone drug in Brazil, consult our regulatory and health registration experts to ensure that all the steps are followed correctly.
Brochure : GRP Brazil Services
GRP Brazil Office provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical, medical device, and life-consumers companies worldwide to register them product with ANVISA the local Health Authority (HA).
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.