Advantages of Registering Biological and Health Products in Brazil

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.

Mexican Ministry of Health Advances with SaMD

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).

Mexico’s Cofepris and U.S FDA agree on vision for the future with 2023 implementation plan.

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.

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 […]