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,
Regulatory News
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
TGA Publishes Specification on Release of Information on Clinical Trials of Therapeutic Goods
On June 2020, The Therapeutic Good Administration (TGA ) of Australia has released The Therapeutic Goods (Clinical Trial Inspections) Specification stipulated under subsection 61(5AB.
Pursuant to Subsection 61(5AA), the legislation permit
Malaysia Issues Guidance Documents on Complaint Handling and Mandatory Problem Reporting for Medical Devices
In line with the objective to assist the healthcare professionals in the industry towards compliance with the Medical Device Act (Act 737), the Medical Device Authority (MDA) has issued a
NPRA of Malaysia Implements Fast-Track Review for Clinical Trials
On 18 June 2020, the National Pharmaceutical Regulatory Division (NPRA) of Malaysia has published a circular announcing a fast-track review for clinical trials applicable for clinical trial import license applications