July 12, 2010
On January 2, 2008 a Decree was published in the Official Gazette in Mexico modifying several provisions of the Regulations for Health Consumables of the Health Law, concerning important issues for the pharmaceutical industry.
The first relevant amendment is that these regulations eliminate the distinction between “generics” and “interchangeable generics”. Before the regulations were enacted, a generic registration could be obtained without proving interchangeability or bioequivalence. With these reforms, all genetic medicines will need to prove interchangeability with a medicine of reference.
Within the amendments concerning generic medicines, the specific requirement to prove safety and efficacy, which was previously contemplated in the regulations, is eliminated and is substituted by the need to prove interchangeability. This may have an impact on data package exclusivity issues, as reliance on the information contained in a reference product’s dossier seem to be necessary for the issuance of generic authorizations.
Additionally, the timelines for the MOH to decide upon the issuance of marketing authorizations are extended from 40 to 180 days for medicines that had been previously registered in Mexico, from 60 to 240 days for medicines registered abroad, from 90 to 180 for new molecules and from 90 to 180 for biological medicines.
Another change addressed in these reforms is the setting of rules concerning the extension of term of marketing authorizations. Accordingly, unless extended, marketing authorization will be in force for five years. The main requirements for these extensions are a technical report for interchangeability in the event of changes affecting the pharmacokinetics of the medicaments and a pharmacovigilance report.
We are performing a through analysis on the impact of these reforms in both the R&D and the generics industry in our country, including judicial and other means to surmount any negative impacts of the reform.