NEW REGULATORY FRAMEWORK OF API
In the series of articles published in March/April as soon as the IFA regulatory framework was published, I raised some questions that worried me because it was not clear how it would be operationalized. Now, on the entry into force of RDC 359/2020, ANVISA has published the ALADIP Administrative Procedures Manual, so let's check which doubts have been clarified and which still need to be answered. The manual can be found at:
ANVISA clarified in the Manual that the holder of APID (Active Pharmaceutical Ingredient Dossier) must register to have access to Anvisa's systems, and indicate his security manager who is the person who will act on behalf of the holder of APID in Anvisa's systems and will have access to all requested information. For international companies it is advisable to have a local representative to play the role of security manager, as this figure can also help to mediate with ANVISA and support the process, helping, for example, in understanding and responding to requirements.
It was is that petitions and communications related to ALADIP will be carried out through Anvisa's systems, where the interface between the holder of APID and the Agency will take place, for the transfer of regulatory information.
Also according to the new manual, the process basically follows the same flow of registration of a drug where ANVISA can issue requirements, the deadline for reply will also be 120 days and there is the right to appeal in case of rejection.
One point of attention is that the ALADIP holder must be prepared to manage the ALADIP life cycle and update it whenever there is a change in the API as this will be very important to avoid ALADIP suspension or cancellation. For this reason, the quality agreement between the holder of the APID and the manufacturer of the drug is essential to have a commitment to this update will occur systematically.
Returning to my questions about the March articles:
1. Are International manufacturers prepared to interact directly with ANVISA?
2. Is ANVISA prepared to interact directly with foreign companies?
I still have doubts about the first two questions, and I anticipate some initial difficulties and only with the beginning of the interaction will it be possible to fine-tune this process.
3. Will there be a representative of the APID Holder in Brazil to make the intermediation?
Fortunately, the answer to that question was positive because, in my view, the Brazilian legal representative will be a key figure to support the registration, submission, receipt, understanding and responses to requirements. In addition, due to a legal restriction, only a Brazilian legal representative can file an appeal against an eventual rejection.
As of the entry into force of the new API Framework, points to be improved will begin to emerge, but I am sure that ANVISA will give all the support and priority to overcome the initial difficulties.