03 June 2020, The Ministry of Health, Labour and Welfare (MHLW) of Japan released a document providing general guidelines for the clinical evaluation of children that can also be evaluated
Regulatory News
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 management of medical device distribution records.
The guidance document is created
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 reviews and strengthen the link between Good Clinical Practice (hereinafter
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 ( FDA ) intends to conduct the inspection from the year,
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 (NMPA) and National Healthcare Commission (NHC) have jointly released the
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 Inspection of Independent Software for Medical Device Production Quality Management
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 essential documents for Drug Clinical Trials. The Guideline has been
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 for medical device advertisement.
The aim of the circular is to
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 holders (hereinafter referred to as “holders”) who carry out pharmacovigilance