Advantages of Registering Biological and Health Products in Brazil
When it comes to health products in Brazil, understanding Anvisa’s regulatory requirements is essential. Two concepts often mentioned in this context are product registration and notification. Although both are necessary processes to guarantee the safety and efficacy of products available on the market, they have important differences in terms of criteria, requirements and procedures.
Review of the Draft Technovigilance Standard by COFEPRIS in Mexico.
Review of the Draft Technovigilance Standard by COFEPRIS in Mexico.
Mexican Ministry of Health Advances with SaMD
The Mexican regulator, COFEPRIS, published the 5.0 edition of the Supplement for Medical Devices in the Mexican Pharmacopoeia, introducing regulatory requirements for Software as a Medical Device (SaMD).
Registration holder for Medical Devices Imported from Mexico
Registration holder for Medical Devices Imported from Mexico.
Mexico’s Cofepris medical Device and IVD Registration and Approval in Mexico
GRP Mexico can help you obtain COFEPRIS medical device registration and approval to sell your product on the Mexican market.
Mexico’s Cofepris has Issued New Guidelines for Changes to Medical Device Registrations
In August 2023, Mexican regulators have updated guidance on rules for modifications to medical device registrations that could streamline COFEPRIS reviews.
Mexico’s Cofepris and U.S FDA agree on vision for the future with 2023 implementation plan.
On February 13, 2023, COFEPRIS released Communicate No. 15/2023, a press communicating, their strategic alliance with the US FDA in the 2023. The strategy discusses primarily, The guarantee of the safety, quality, and efficacy of medicines in Mexico and the United States. Secondly, That Both authorities work on food safety for the benefit of the health of the populations of both nations.
FDA-Advancing Real World Evidence Program
On October 2022, the U.S. Food and Drug Administration is announcing the Advancing Real-World Evidence (RWE) Program
The US FDA deems final Order for Sunscreens
On September 24, 2021, FDA took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter (OTC) drugs.
FDA publishes ICH Q12 guideline for Post Approval CMC changes
Overview FDA facilitates the management of post approval CMC to harmonize regulatory approval of drugs with ICH Q12 guideline. This guidance applies to pharmaceutical drug substances and products (both chemical and biological) that require a marketing authorization and to drug-device combination products that meet the definition of a pharmaceutical or biological product. Regulatory tools and […]
Australia’s TGA GMP inspections during COVID-19
During the duration of the COVID-19 pandemic, the TGA will only use remote and hybrid inspections to minimize potential impacts of on-site inspection of GMP clearance.
Anvisa Introduces Pilot Program to Increase Quality of Health Products
Anvisa instituted the Pilot Program to Expand the Quality of the National Health Products Industries, through Ordinance 680/2020. The objective is to strengthen the industries manufacturing health products classes III and IV in the country.