Removal Of ‘Legal’ And ‘Implicit’ Terms Cleared Way For ICH Q12 Guideline
Concerns about potential regional variation and ambiguous applicability subside with final revision of lifecycle management guideline; training preparations begin.
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New approach could eliminate minor differences among authorities, enabling pharmaceutical manufacturing processes to become truly global.
An international guideline on managing post approval changes to drugs, which was initially criticized because of its incompatibility with legal frameworks in certain ICH regions such as the EU, has been finalized.
Reducing dependence on Type II variation fees would free lifecycle management guideline from European Commission’s legal concerns.