Regulatory

Abstract

Since 2017, it has been mandatory for suppliers of APIs, excipients and packaging materials to register their material in China on the DMF registration platform. While many agencies ask for details of a component’s quality and its impact on products, the Chinese requirements for 'high risk' materials, such as those used in biopharmaceuticals, also ask for historical information that is typically proprietary which many suppliers are reluctant to share. This paper summarizes the requirements for raw materials in other ICH countries and compares these to the Chinese approach. The paper also lists all of the details needed for the Chinese registration of biopharmaceutical products' raw materials in a single place, to help suppliers register their products into this vast market.

Abstract

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.

Abstract

The leaders and representatives of BioPhorum Cell and Gene Therapy have reviewed and provided feedback as part of the consultation with the EMA on the draft Regulatory Science to 2025 strategy reflection document.

Abstract

In 2020 the Russian agency adopted a new testing regimen for biological imports, that moves from testing all batches to testing the first imported batches and then potentially only annually. While the changes are intended to support industry and align with procedures in other regions there is concern that some parts of the approach and unintended consequences may worsen the supply of biological products to patients. This paper makes a series of proposals and recommendations to mitigate these concerns and help alignment between the Russian Federation requirements and those of other prominent agencies.