Mexico Modernises Drug Manufacturing Registrations

Industry bodies in Mexico have welcomed a reform that obliges drug manufacturers to renew product registrations. The measure, which amends Article 37 of the country's General Health Code, will replace the previous regulations and oblige manufacturers to renew registrations every five years. Producers will also be required to demonstrate bioequivalence before starting production of a new drug.

Although generic producers have been subject to this provision since 1997, such requirements were previously voluntary. Official sources now claim that the amendment marks a further step towards compliance with standards in ICH countries, which have pledged to harmonise drug regulations in the developed markets of the US, Canada, Japan and the EU.

The multinational sector has also welcomed the increased certainty offered by the reforms. However, sources at Roche Syntex Mexico, the local unit of Swiss drugmaker Roche, have cautioned that the country's recently strong progress on regulatory reform may not drive up growth in the short term. Other industry sources, while also positive on the opportunity to remove dubious "miracle cures" from the market, warn that Mexico's generally sluggish economic growth could dampen overall sector performance in 2005. Further, it is worth noting the relatively low penetration of generics in Mexico, Latin America's largest drug market. In the meantime, the sector awaits a substantial rise in multinational sector investment.