• Inovatie Serviços em Saúde

NEW API REGULATORY FRAMEWORK: Will ANVISA and international manufacturers be prepared?




Continuing the series on the API regulatory framework, a major innovation is that the request for regularization of the API must be made by the API Holder who is the Manufacturer of the API or Company that owns the Technology. But what is the impact of this paradigm shift?

I begin by raising some questions:

1) Are the International manufacturers prepared to interact directly with ANVISA?

2) Is ANVISA prepared to interact directly with foreign companies?

3) Will there be a representative of the APID Holder in Brazil to make the intermediation?

Throughout my career I have had the opportunity to interact numerous times with the headquarters abroad or international partners and this interaction can be potentially complex:


· ANVISA's requirements are not always clear and direct enough, they may not specify exactly what ANVISA wants, and a simple English version is generally not enough to clarify the foreign company on how to comply with the requirement.

· International companies have a different logic than companies used to operating in Brazil because they do not have the necessary flexibility to deal with ANVISA. Responses to requirements are usually simplistic yes or no, accepted or not, to clearly state that the request has no logic and, as a rule, needs to be worked on before being sent to ANVISA.

In the old system, there was the help of the applicant for the registration of the medication to assist in the correct interpretation of what was requested, in order to explain what was, or not, possible to negotiate, and do the midfield with ANVISA. But and now? Will there be a possibility of having a representative from API holders here in Brazil to mediate with ANVISA? Is it possible that the drug manufacturers themselves act as intermediaries in this process? Pharmaceutical companies must be aware of these issues and demand ANVISA's answers.

If this is not possible, in my view, ANVISA will have to go through a learning process taking care to be very specific and enlightening in what is being requested and explaining the reasons based on ICH guides, in addition to being flexible in analyzing the requirement and reiterating some points with new explanations for the other party to understand and be convinced of the need to comply with the item.

The positive aspect of this issue is that the administrative document requirements for obtaining the ALAPID are really very simplified containing only one petition form, and the risk assessment for transmission of transmissible spongiform encephalopathy and the APID quality documentation must be structured according to the module the active pharmaceutical ingredient (3.2.S) of the Common Technical Document (CTD) and ICH guides, which will facilitate the understanding of what should be presented to ANVISA by international manufacturers.


Another point of great attention is the issue of the APID life cycle, as the companies that hold the APID must keep the dossiers up to date and file the post-obtaining changes to ALAPID, the logic being practically the same as that of post-registration of medicines. because they are divided into:

· Changes in annual notification and immediate notification that do not depend on prior knowledge or manifestation by ANVISA for implementation.

· Annual notification changes that must be filed within 12 months from the date of implementation.

· Changes in immediate notification to be filed after the date of implementation.

· Minor and major changes must await ANVISA's manifestation for implementation or the maximum period for ANVISA's manifestation to elapse, which is up to 60 days from the receipt of the documentation, for minor change, or 180 (one hundred and eighty) days for change greater, the change can be implemented.

ANVISA listed the main changes in Annex II of the DRC where it details and classifies the types of changes, and for each there are several sub-types classified according to complexity and framed in the types of petitions described above.

If the issue of updating API's post-registrations is already a complex one, being under the responsibility of the drug registration holders, from the moment it passes into the hands of the APID holder, it can become more difficult to manage. The quality and commercial agreements become vital and should provide for the responsibilities and consequences of not carrying out the necessary updates to the APDI, it is not too much to remember that the biggest loser in case of suspension of the APID is the manufacturer of the drug.

In the next article we will cover the certification of good manufacturing practices for the API manufacturer and the technical requirements of the API in the drug registration dossier.




5 views0 comments