Japan Release Document on Clinical Evaluation of Pediatric Population along with Adults
03 June 2020, The Ministry of Health, Labour and Welfare (MHLW) of Japan released a document providing general guidelines for …
Malaysia Publishes Guidance Document for Medical Device Distribution Records
On June 2020, Medical Device Authority (MDA) of Malaysia has published a guidance document to set a framework for the …
Taiwan to Conduct GCP Inspection in Compliance with New Drug Applications
Taiwan Food and Drug Administration (FDA) published a guideline on 28 May 2020 to improve the efficiency of new drug …
Taiwan Intends to Implement Inspection scheme for Bioequivalence Trial ( in 2021)
Towards an aim to ensure the quality and data management of bioequivalence study, the Taiwan Food and Drug Administration ( …
NMPA of China Releases Chinese Pharmacopoeia 2020
Upon the review and approval of the plenary meeting of 11th Pharmacopoeia Commission Executive Committee, China’s National Medical Products Administration …
China Publishes Guidance for Medical Device Good Manufacturing Practice On-Site Inspections on Standalone Software
On 29 May 2020, the National Medical Products Administration ( NMPA) of China has formulated a “Guiding Principles for On-site …
NMPA Issues Guideline on Management and Archiving of Required Documentation for Drug Clinical Trials
The National Medical Products Administration (NMPA) of China has released a circular as a guiding principle for the preservation of …
Malaysia Issues Circular on Transition Period for Medical Device Advertisement
On 20 May 2020, the Medical Device Authority (MDA) of Malaysia has issued a circular pertaining to the transition period …
China Releases Guidelines for Preparing Pharmacovigilance Outsourcing Agreement (Interim)
4 June 2020, The China National Centre for Adverse Drug Reaction (ADR) Monitoring releases guidelines applicable for drug marketing license …