EU Drug Review "Should Start In Early R&D"

The only way a substantial reduction can be made in the review time for New Drug Applications is to commence the review before Day Zero, with regulators commencing their examination of the data during the drug's development, according to Kjell Strandberg, director general of Sweden's Medical Products Agency, and a member of the European Union's Pharmaceutical Committee and Committee for Proprietary Medicinal Products.

Giving the annual address at the British Institute of Regulatory Affairs in London last week, Prof Strandberg said that as regulators will, under the new European Union drug licensing procedures, be spending less time "duplicating" review efforts, resources previously used in this area should be transferred to discussions with manufacturers in the early phases of drug development. The ultimate goal here is that, with the regulatory clock being stopped less often, the new drug's first assessment should also be final.

The new European system is in its transitional or investment phase, according to prof Strandberg; now is the time to flesh out the blueprint. He noted that many differences in drug evaluation criteria still exist in the member states as a result of varying medical practices, notably for products such as antibiotics and anticancer drugs, and these should be done away with. If we cannot settle these differences the result will be arbitration in new drug approvals, which is not good for the credibility of the system, he said.