ANVISA of Brazil received the approval to become a member of PIC/s (Pharmaceutical Inspection Co-operation Scheme) in November 2020. Considering the pandemic situation, for the first time in PIC/s history, the assessment was completed in a written procedure as opposed to at a meeting; on Jan 1, 2021, the PIC/s committee welcomed ANVISA as their 54th valuable member.
The other 53 members of PIC/s come from 50 nations worldwide. As the PIC/s guide is used for both human and veterinary medicines, some countries have multiple authorities as a member/member authority.
The process of becoming a member usually takes 4-5 years and consists of two stages – Pre-application & Application. It demands the Health Authority to undergo an extensive elevation in its system & procedures. Also, to complete the checklist of standards specified by PIC/s to reach the level of standards of the current member authorities. Obtaining the approval of membership reflects that ANVISA has satisfied all the expectations of PIC/s by uplifting its legislation, inspection procedures, Quality System, inspector training, etc., and is obliged to maintain the same.
With the membership of PIC/s, there will be a lot of instrumental advantages. ANVISA will experience considerably enhanced credibility and recognition on a global level. Added advantages like regular assessments of Regulatory framework & performance, training opportunities, involvement in PIC/s Rapid Alert & Recall System, simplicity in closing bilateral agreements will help ANVISA in retaining the global GMP standards.
Along with the health authority, the health industry will also enjoy a fair number of advantages. Adopting PIC/s codes will reduce duplication of inspections, save time & financial resources, increase export and eventually open access to greater markets.
Also, the drugs produced in a member country will be considered a quality product and holding a GMP certificate approved by PIC/s will no longer require thorough evaluation and inspection, enabling fast approval of the product. Taking the COVID-19 situation into account, ANVISA, as a member of PIC/s helps in emergency vaccine approvals, which is the biggest advantage to the Brazilian health care industry.
Brazil is the leading pharma market in Latin America and the 6th largest market globally. Acceptance as a member of PIC/s will open endless opportunities in the Brazilian pharma sphere. If you are looking for any regulatory assistance in Brazil, you can always opt for an expert. Stay informed. Stay updated.