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.
A strong bond
Initially, the Phorum helped the agency with its post-approval change process. This had been a lengthy activity, partly because of some of the agency’s specific requirements for these changes but also because they were not aligned with other agencies. The Phorum has therefore worked with Anvisa on new versions of its regulations and new stability requirements for post-approval changes.
Various factors make the BioPhorum/Anvisa relationship so strong. These include:
· continuity of staff in both teams
· regular participation from BioPhorum’s local affiliates in any interaction with Anvisa
· Maria Fernanda, Anvisa’s Regulatory Specialist and the CMC Regulatory Biologics Team leader, is very open to collaboration with BioPhorum and other industry groups and agencies
· More generally, Brazil’s political environment is open to collaboration, as shown by the recent pilot project on GMP inspection of medicines and pharmaceutical supplies between Anvisa and the Swiss regulatory authority.
The relationship is mutually beneficial. Anvisa benefits by hearing ‘one voice’ from the industry on specific topics. For example, in its recent public consultation on new regulations for stability and post-approval change requirements, the agency received one set of comments from BioPhorum that expressed the views of the industry, which simplified and accelerated Anvisa’s review process. Meanwhile, the BioPhorum team is seeing more alignment of Anvisa’s requirements to WHO and ICH guidelines and convergence towards a common regulatory model—all of which BioPhorum has been pushing for at an industry-wide level.
Continuous manufacturing workshop
This strong relationship is shown in recent discussions on continuous manufacturing for large molecules. Although Anvisa has never received a submission in this area, it wanted to be prepared for when it did, so it asked BioPhorum for help getting upskilled in that field.
As a result, the BioPhorum Continuous Downstream Processing team arranged a workshop for Anvisa with BioPhorum members who are technical and regulatory experts on continuous manufacturing. The result was a very interactive discussion between all parties.
The workshop covered everything from the potential benefits of continuous manufacturing for biologicals (for patients, industry and health agencies), the challenges of implementing continuous manufacturing (e.g. bioburden control and defining standard terminology such as ‘batches’ and ‘lots’), the complexity of equipment and the criteria for automation. Anvisa was also shown an example of continuous manufacturing through a session on Bayer’s MoBiDik facility.
An important part of the two-way nature of the workshop was asking about Anvisa’s experience with continuous manufacturing, its expectations of a submission and the role of ICH Q13 in promoting the harmonization of continuous manufacturing concepts. A sign of the success of the workshop was that these discussions continued informally after the session ended.
“The workshop was an excellent opportunity to get to know the Anvisa reviewers, and gain a sense of their level of knowledge of continuous manufacturing,” said Millena Tascone, Regulatory Affairs Manager at Eli Lilly in Brazil. “It was notable that they recognize not only the importance of this subject, but also for the Brazilian regulatory framework to be aligned with future ICH guidelines.”
We hope that BioPhorum’s relationship with Anvisa will continue to develop, with more opportunities for learning and engagement for both sides, as well as more initiatives to drive towards harmonization of the submission and review processes for post-approval changes.