South Korea MFDS issues 3 Q&As relating to GMP, Official Communication Channel , Drug Approvals and other topics

South Korea Ministry of Food and Drug Safety (MFDS) has issued 3 Q&As in late-November/early-December 2020 relating to GMP, Official …

read more...

Malaysia Updates Guideline for the Application of Clinical Trial Import License (CTIL) and Clinical Trial Exemption(CTX)

On August 2020, the NPRA of Malaysia has updated a document intended to guide the applicant in making Clinical Trial …

read more...

China CDE Releases a Guideline on Non-Inferiority Clinical Trials for Drugs

Effective from 24 July 2020 onward, the Center for Drug Evaluation(CDE) of China releases a guideline on Non-Inferiority Clinical Trials …

read more...

China Releases Working Procedures for Breakthrough Therapy Drugs, Conditional Approval and Priority Review

In order to support the implementation of the new Regulations of Drug Registrations, The National Medical Products Administration(NMPA) of China …

read more...

NMPA Issues Rules for Development Safety Update Reports(DSUR)

On 01 July 2020, China’s NMPA’s Center for  Drug Evaluation(CDE)  has issued administrative rules titled “Management Guidance/Standard for Development Safety …

read more...

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 …

read more...

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 …

read more...

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 ( …

read more...

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 …

read more...

More News