Driving the harmonization of regulatory requirements – one country at a time Regulations play a significant role in assessing marketing authorizations for drug products that are submitted for approval. Yet, regulatory agencies often differ in their degrees of harmonization. This has created an environment of divergence, in which countries each have unique standards, requirements, submissions and review processes. The potential...
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There are many things that make a relationship work, such as trust, honesty and mutual respect. And a sign of a strong relationship is someone asking for help when they don’t know how to do something.
Forging strong relationships is at the core of BioPhorum’s success. This can be seen in its Drug Substance Phorum Post-Approval Strategy Team’s work with the Brazilian Health Regulatory Agency (Anvisa) over the last three years.
Slicing years off change implementation Harmonizing post-approval change regulations As the first regulatory authority in Latin America to gain full membership of the International Council for Harmonization (ICH), the Brazilian Health Regulatory Agency (Anvisa) asked BioPhorum to support it in its review of national regulations relating to post-approval change (PAC) submissions. Brazil’s regulations, RDC50 about the stability data required to...
Post-Approval: General recommendations for harmonization of local regulations for post-approval submissions with WHO and ICH guidelines, example Brazil
As the first regulatory authority in Latin America to gain full membership of the International Council for Harmonization (ICH), the Brazilian Health Regulatory Agency (ANVISA) asked BioPhorum to support review of its Post-Approval Change regulation to bring it in line with ICH, but also global WHO guidelines . Brazil’s stability and manufacturing data requirements typically delayed submission of post-approval changes by several months to years. The paper demonstrates how to align the national regulation with international standards, resulting in quicker submissions as well as a more efficient review process for the agency.