Third-Party Authorized Centers

Sat, 09/05/2015 - 13:11

In March 2011, the federal government launched a strategy that aimed to reinforce the position of COFEPRIS as sanitary regulator and strengthen the pharmaceutical policy, which had a backlog in the issuance of 8,000 applications for health supplies and long approval times. This was largely due to every document filed in COFEPRIS being processed through a single authorization lane. To expedite the sanitary authorization process, specialized lanes were implemented under a risk-based approach, enabling products to be properly categorized and evaluated. In addition, two months later, in June 2011, public calls for authorized third parties were published in the Official Journal of the Federation, with the objective of reducing sanitary authorization waiting times from two years to four months.

Third-party centers are entitled to evaluate the submissions of pre-dossiers, modifications, and renewals of sanitary registrations for medical devices or allopathic drugs, vitamins, and herbal drugs. In addition, they can conduct verification visits for the certification of good manufacturing practices. There are 18 authorized third-party companies currently in operation and, to date, 3,561 products have been authorized in less than 20 days. This has allowed COFEPRIS to significantly reduce the processing time of each individual filing. For instance, processing times for new product registrations have been reduced by two years on average. The approval of these registrations was carried out by 86 evaluators in the verification units, who contribute to the activities performed by 138 evaluators in COFEPRIS. In this way, besides being a unique model in the world, third- party centers represent the right arm of COFEPRIS when it comes to improving processing times, which are now competitive in global markets.