European regulation model for herbal medicine: The assessment of the EU monograph and the safety and efficacy evaluation in marketing authorization or registration in Member States

Author:

Qu Liping,Zou Wenjun,Wang YiTao,Wang Mei

Publisher

Elsevier BV

Subject

Complementary and alternative medicine,Drug Discovery,Pharmaceutical Science,Pharmacology,Molecular Medicine

Reference15 articles.

1. The Complete German Commission E Monographs;Brinckmann,1998

2. Co-ordination group for 2013. Mutual recognition and Decentralised procedures-human. Q&A traditional herbal medicinal products. http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Questions_Answers/CMDh_287_2013_Rev1_2013_02_clean_.pdf.

3. European commission, 2016. Volume 2A procedures for marketing authorization Chapter 3 Union referral procedures. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/vol2a_chap3_rev201612.pdf.

4. European Medicines Agency, 2014. Questions & Answers on the EU framework for (traditional) herbal medicinal products, including those from a ‘non-European’ tradition. http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2014/05/WC500166358.pdf.

5. Standard operating procedure on establishment of European Union herbal monographs,2016

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