During the week, the processes of many global regulatory bodies were discussed. This session answered burning questions surrounding the Brazilian Health Surveillance Agency (ANVISA) and its latest regulatory changes and ongoing challenges.
The panel featured:
Dr Patricia Kott Tomazett, Health Regulation Specialist, General Management of Drugs, GGMED, ANVISA
Dr Thomas Kirchlechner, Director Regulatory Policy Biosimilars, Sandoz GmbH
Darius-Jean Namdjou, Global Regulatory Strategist, Grünenthal GmbH, Germany (Moderator)
First, Dr Patricia Tomazett provided an update on the status of eCTD v4.0 adoption by ANVISA. The adopted version will definitely be 4.0, and currently the agency is working on the implementation of a number of technical aspects.
Dr Thomas Kirchlechner answered a question on the debate about the interchangeability between biosimilars and the perceived lack of a harmonised approach between regions. He believes that there are misconceptions about the interchangeability requirements, with an expectation for stricter interchangeability requirements in the USA, which is not the case. Notably, many countries that have not developed their own requirements follow the requirements of the World Health Organisation (WHO).
The next question concerned the harmonisation of regulations in light of the COVID-19 pandemic. Dr Tomazett explained that ANVISA wants to keep an open channel for communication with the industry to help streamline the harmonisation process. It is important to follow the national guidelines related to ICH regulations, and to discuss any potential difficulties a company may face in the implementation of the ICH guidelines adopted by ANVISA.
Several questions focused on specific ANVISA regulatory processes. One question addressed the requirement for local studies for generic drugs in Brazil. Dr Tomazett explained that there are specific requirements regarding bioequivalence and clinical studies for generics.
The bioequivalence study centre has to be certified by ANVISA but does not need to be located in Brazil. There are also certain requirements regarding the report completeness and data quality for clinical trials for generics; however, it is not necessary to conduct the clinical study in Brazil or on Brazilian subjects.
Next, the timelines and steps for orphan drug registration in Brazil were discussed. Dr Tomazett explained that a pre-submission meeting is mandatory to review the documents for orphan drug registration, followed by a 60 days review procedure and the exchange of questions and additional information. With regard to the recent variation stability guidelines for biologics in Brazil, Dr Tomazett clarified that there will be a transitional period.
Dr Kirchlechner shared key learnings from his experience with the approval of biosimilars in Brazil. He pointed out that transport validation should be planned early on, and that a dialogue with ANVISA should be initiated promptly to ensure compliance with Brazil-specific requirements. Moreover, he believes that the new eCTD format will facilitate the process. His advice to new companies trying to register a drug in Brazil is to do a thorough market research for an existing product development partnership (PDP). If there is one, it may not make sense to develop a second molecule. If no PDP exists for the molecule of interest, it may be reasonable to enter in a PDP and to introduce technology in Brazil, which will give the company an advantage with the market share.
The final questions again focused on ANVISA regulatory processes. Dr Tomazett explained that the new API regulation in Brazil implements many ICH guidelines and will have a transitional period until next year. Regarding the inspection of global manufacturing sites by ANVISA, Dr Tomazett explained that ANVISA has applied for a PIC/S certification. Until a positive result on the PIC/S certification is achieved, ANVISA will continue to inspect global sites. When a PIC/S certification is acquired in the future, ANVISA will be able to accept the reports of local authorities.
