Active Pharmaceutical Ingredients

Publicado em 29/10/2020 16h32

Which API are subject to pre-market approval by Anvisa?

According to Resolution RDC 57/2009 , APIs produced nationally or imported cannot be industrialized, exposed to sale or marketed in the Brazil without the mandatory pre-market approval by Anvisa. The exception are the active pharmaceutical ingredient which will be used for scientific or technological research, as well as for the research and development of formulations.

The APIs present in the imported drugs composition, whether under the form of semi-elaborated or finished product, are thus subject to pre-market approval by Anvisa.

At this time, APIs of vegetable origin are not subject to pre-market approval by Anvisa, but their manufacturing must comply with the current GMP.

Market authorizations

As set forth by Norms IN 15/2009 and IN 03/2013 , the following APIs must apply for pre-market approval: Cyclosporine; Clozapine; Clindamycin hydrochloride; Cyclophosphamide; Ciprofloxacin; Methotrexate; Carbamazepine; Lithium carbonate; Phenytoin; Phenytoin Sodium; Lamivudine; Penicillamine; Thiabendazole; Efavirenz; Nevirapine; Rifampicin; Ritonavir; Zidovudine; Acyclovir; Ampicillin; Azithromycin; Benzylpenicillin; Cabergoline; Carboplatin; Cephalexin; Cephalothin; Ceftazidime; Cisplatin; Clarithromycin; Ceftriaxone. The pre-market approval is also applicable to all salts, esters, ethers and hydrates of the above-mentioned APIs.

Pre-market approvals are valid for five years from the date of their publication in the Brazilian Official Gazette, and may be renewed for equal and successive periods.

In order to obtain the pre-market approval for a finished drug product, it is mandatory that the API also obtains a pre-market approval by Anvisa. Nevertheless, these are two different authorization processes: each request must be submitted separately, following the directives for each submission and each will have an independent authorization number. The submission for the API may be presented before the request for market approval for the finished drug product.

Please note that it is not possible for foreign companies to make administrative arrangements for issuing market authorizations directly with Anvisa. Foreign companies shall have partner companies legally constituted in Brazil that will be legally responsible for the products imported to and distributed in the Brazilian territory.