Hong Kong Drug Office Updates Frequently Asked Questions’ Page

Hong Kong Drug Office has updated and included the latest set of frequently asked questions (FAQs) on their official website …

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Singapore HSA Announces Update on Regulatory Fee Revision for Health Products

The Health Sciences Authority (HSA) Singapore has announced a critical update regarding the revision of the regulatory fee for health products, which was published on the …

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NPRA Malaysia and MDA Malaysia Issues Updated Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products

National Pharmaceutical Regulatory Agency (NPRA) Malaysia and Medical Device Authority (MDA) Malaysia have issued an updated guideline, which is the …

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Singapore HSA Publishes Document on Common Questions for Generic Drug Applications

The Health Sciences Authority (HSA) Singapore has published a document on the common questions received for Generic Drug Applications in September 2021. The document highlights …

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NPRA Malaysia Issues Updated Guideline for Application of Clinical Trial Import Licence and Clinical Trial Exemption

National Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued an updated guideline on clinical trial import licence (CTIL) and clinical trial exemption (CTX) in September 2021.   The updated guideline …

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Philippines FDA Issues Circular on Revised Post-Marketing Surveillance Requirements for New Drugs under Monitored Release

The Philippines Food and Drug Administration (FDA) has issued Circular No. 2021-020 to provide updated post-marketing surveillance (PMS) requirements for new drugs under monitored release, …

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China NMPA Implements Drug eCTD Submission

On 30 September 2021, China NMPA issued an announcement No. 119 of 2021 regarding implementation of drug eCTD submission.   From December 29, 2021, applications for …

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NPRA Malaysia Issues Updated Guidance Document on Foreign GMP Inspection

National Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued an updated guidance document on foreign GMP inspection in August 2021.  The main update is …

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NPRA Malaysia Issues Updated Guidelines for Pharmacovigilance

National Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued two updated guidelines for pharmacovigilance in August 2021.   The updated guidelines are:  “Malaysian Guidelines on Good …

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