Technical Requirements for Clinical Development of Overseas-marketed and Domestic-non-marketed Products

On 12 October 2020 the Chinese CDE of NMPA issued notification No. 29 on technical requirements.

The guideline applies to clinical development considerations for overseas-marketed and domestic-non-marketed reference products as well as generics. The clinical evaluation rationale covered in the guideline is based on clinical needs assessment, efficacy and safety evaluation and clinical trial requirement.

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