Pharma regulations signal new regime for generic registrations

On 2nd January 2008 a decree was published in the Official Gazette modifying several provisions of the Regulations for Health Consumables. These form part of the Health Law and deal with important issues for the pharmaceutical industry.

The new decree eliminates the distinction between ‘generics’ and ‘interchangeable generics’. Previously, generic registration could be obtained without the need to prove interchangeability or bioequivalence. However, further to the reforms, all generic medicines will need to prove interchangeability with a medicine of reference.

In addition, the decree removes the specific requirement to prove safety and efficacy in generic medicines; in its place is the need to prove interchangeability. This will have an impact on issues of data exclusivity, as reliance on the information contained in a reference product’s dossier appears to be necessary for the issuance of generic authorisations.

Additionally, the timelines for the Ministry of Health to decide upon the issuance of marketing authorisations has been extended from: 

• 40 to 180 days for medicines that had been previously registered in Mexico; 
• 60 to 240 days for medicines registered abroad; 
• 90 to 180 days for new molecules; and 
• 90 to 180 days for biological medicines.

The reforms also change the rules concerning term extensions for marketing authorisations. Accordingly, unless extended, marketing authorisations will be in force for five years. The main requirements for an extension are (i) a technical report for interchangeability in the event of changes that affect the pharmacokinetics of the medicine, and (ii) a pharmacovigilance report.