EMA Expands International Assessments of Generics Applications
The European Medicines Agency has extended its pilot program for coordinating international generic drug applications. Under the pilot, drugmakers can make joint submissions through the EU’s centralized procedure and the regulatory authorities of Australia, Canada, Taiwan and Switzerland.
Initially, 10 applications will be considered under the International Generic Drug Regulators Pilot. Others may be considered once those results are evaluated, the EMA says.
Submissions from generics makers that wish to participate in the pilot are due by March 31. The reviews must include at least one of the other participating international regulators, in addition to the EMA.
Other countries such as Brazil, China, Japan and South Korea may join the program at a later stage, the EMA says.
Participating companies must synchronize their submissions and sign off on having their data shared between participating countries in real-time. The goal is to facilitate international drug filings and ultimately increase the efficiency of review across national borders.
Firms will also have to justify any differences between the products they’re pursuing in the EU and in the other regulatory jurisdictions. Only solid oral immediate release therapies and solutions such as injectables and oral drugs are eligible.
The centralized procedure pilot follows one based on the EU’s decentralized procedure. Under that program, launched in July, participating generics makers can seek to have information shared between participating international regulators and at least two EU member states. Europe’s decentralized procedure involves parallel generics applications for previously unapproved medicines in at least two EU member countries.
For more information on the pilot program, go to www.fdanews.com/01-20-15-EMA-Generics-Pilot.pdf. — Bryan Koenig