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 some questions and answers relating to Bioequivalence (BE) study requirements
Regulatory News
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 includes some information on First-in-Human (FIH) studies, and NPRA has decided
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, streamlined with Administrative Order (AO) No. 67 s. 1989 “Revised Rules
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 the boundaries between regulated and unregulated software. Software based medical devices are discussed in
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 marketing authorisation of chemical drug categories 1, 5.1, and for therapeutic
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 detailed information on the priorities, which are product regulation and safety,
Philippines FDA Issues Circular on the Reference List of Class A Medical Devices
The Philippines Food and Drug Administration (FDA) has issued Circular No. 2021-017 on the 16th of August 2021, to guide manufacturers, importers, distributors, and other stakeholders in the medical device industry regarding the list of medical devices classified as Class A. The circular will
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 regarding the “GMP Distant Assessment (DiA)” for foreign production facilities, which is effective from
Australia TGA Publishes Document on Refinements to the Personalised Medical Device Framework
Therapeutic Goods Administration (TGA) Australia has published a document regarding the refinements to the personalised medical device framework in August 2021.
After a public consultation regarding proposed refinements in July 2021, the refinements that have been included are