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 …
Australia TGA Publishes Guidance Document on Reclassification of Medical Devices in Direct Contact with the Heart, Central Circulatory and Central Nervous Systems
Therapeutic Goods Administration (TGA) Australia has published a guidance document on the reclassification of medical devices in direct contact with the heart, central circulatory system (CCS) and central nervous …
Australia TGA Publishes Updated Guidance Document on Medical Device Patient Information Leaflets and Implant Cards
Therapeutic Goods Administration (TGA) Australia has published an updated guidance document on medical device patient information leaflets (PIL) and implants cards (including acceptance of Implementation Plans) in October 2021. The …
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 …
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 …
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, …
Australia TGA Publishes Finalised Guidance Document on Examples of Regulated and Unregulated Software
Therapeutic Goods Administration (TGA) Australia has published the finalised guidance document on examples of regulated and unregulated software in August 2021. The guidance document presents examples that illustrate …
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 …
Australia TGA Publishes Business Plan for 2021 and 2022
Therapeutic Goods Administration (TGA) Australia has published a document regarding its business plan and the priorities for 2021 and 2022. The business plan contains …