On 26 August 2019, the Standing Committee of the National People’s Congress approved the revised Drug Administration Law (DAL). The revised DAL will come into effect on 1 December, 2019. New rules addressing market demands and social issues were incorporated into the comprehensive revision. These changes aim at rewarding drug innovation and discouraging misconduct.
Some fundamental changes of the DAL are adoption of the Marketing Authorization Holder (MAH) system, cancellation of compulsory GMP and GSP certification, implementation of whole-process supervision, and increased penalties for drug-related violations.
The European Chamber welcomes Ms. Wang Yi, Lawyer and Head of Beijing at Norton Rose Fulbright and Ms.Zhang Hua, Vice President Site Head of Research & Development Beijing Head of Regulatory Affairs - China, Bayer Healthcare to introduce the changes, opportunities and challenges brought by the revised DAL. They will also further discuss how these revisions may impact R&D and foreign investment in China.
Agenda
09:00-09:30 Registration
09:30-09:40 Welcome remarks
09:40-10:10 Presentation by Wang Yi, Lawyer, Head of Beijing, Norton Rose Fulbright
10:10-10:40 Presentation by Zhang Hua, Vice President Site Head of Research & Development Beijing Head of Regulatory Affairs - China, Bayer Healthcare
10:40-11:10 Moderated discussion and Q&A
Views expressed by invited speakers do not necessarily reflect the opinions or position of the European Union Chamber of Commerce in China
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