China’s NMPA Introduces New Revised Regulation for Drug Approval by Foreign Companies

Asia, China, clinical, compliance, drug, European Union, Guidances, importation, Japan, Markets, National Medical Products Administration (NMPA), Regulatory, United States / By

Overview: China’s National Medical Product Agency (NMPA) proposes a revision on pharmaceutical approval. The revision focuses mainly on generic drugs and how to increase the safety requirements for clinical trials, limit false clinical data and encourage drug approval process. China additionally released the second batch of urgently needed drugs from foreign manufacturers.  New Drug Review …

China’s NMPA Introduces New Revised Regulation for Drug Approval by Foreign Companies Read More

Singapore’s HSA Announces Guidance on 3-D Printing on Essential Medical Device for COVID-19

ASEAN, Asia, blogs, compliance, COVID-19, Guidances, Health Science Authority (HSA), importation, Markets, Medical Device Registration, Medical Devices, public health emergency, Quality, Regulatory, Singapore, Singapore / By

The Health Science Authority (HSA) released a guidance in response to the COVID-19 demand for medical devices like nasopharyngeal swabs, personal protective equipment, face shields and respiratory accessories.

China’s NMPA issues Guideline for changes of Raw Material in Passive Medical Device Products.( No. 33 2020)

Asia, blogs, China, COVID-19, Markets, Medical Device Registration, Medical Devices, National Medical Products Administration (NMPA), News, Pre-market submission, Preventative Measures, public health emergency, Regulatory / By

China’s NMPA issued a guidance (No 33. 2020) on May 19, 2020 to provide a guideline and systematic approach for risk analysis of raw material changes in passive medical device products .

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