Starting in 2012, the possibility of having submission dossiers pre-revised by private parties especially authorized by COFEPRIS in order to reduce revision times later was introduced.
How does it work?
The pharmaceutical company that intends to register a drug product, contacts an authorized third party, which is an independent professional or company that has gone through an exam to be especially authorized by the health authority to pre-revise dossiers. The relations (conditions of confidentiality, timings, prices, communication arrangements) are specified in a contract between the Authorized Third Parties (ATPs) and the client, and COFEPRIS doesn’t have any inference into that.
After the company sends the dossier and documents, and the parties have all the necessary meetings and exchange of information, the ATP will issue a technical report. If this final report is positive, it can be attached to the submission package for drug registration. This submission package will enter the COFEPRIS through a special fast-track channel and will be revised in a much shorter time than applications going through the conventional channel.
This option is available for new drug applications, renewal of registration certificate and variations of allopathic drugs (small molecules), both innovative and generic, and will be soon be introduced for biotech products. (COFEPRIS has just called for professionals interested in providing this service – August 2013)
Utilizing an Authorized Third Party has two main benefits:
- Cut current revision times significantly.
- Avoid unnecessary deficiency letters.
It is necessary to mention that the technical report that the ATP issue does not replace the evaluation and decision by COFEPRIS, that will base its decision also on other factors other than the perfection of the dossier, such as benefit/risk assessment of the proposed product in the local market.
Despite the initial skepticism from companies and regulatory professionals around the world, we can already see very positive actual results. On average, the COFEPRIS is taking 4.5 months to approve a new registration (average without ATP scheme: 30 months), 3.75 months for renewal of marketing authorization (otherwise: 6 months) and only 15 days for decisions on variations. (otherwise: 2 months)
Last update: October 2013