OBSERVATION'S |
The new regulations - changes to Japan's Pharmaceutical Affairs Law - are intended to help Japanese drug companies better compete in the global pharma. arena. Among their provisions is a shift from mfg. to marketing-based new-drug approvals. The change will lift restrictions on drug companies that made it difficult for them to outsource mfg of intermediates & active ingredients to third-party companies. Although the outsourcing-related aspects of the law won't take effect until next year, drug companies are already reacting to the new flexibility |
UPDATE | 05.02 |
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