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
read more...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,
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
read more...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
read more...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
National Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued two updated guidelines for pharmacovigilance in August 2021.
The updated guidelines are:
“Malaysian Guidelines on Good Pharmacovigilance Practices (GVP) for Product Registration Holders, First Edition, August 2021” (effective
read more...With effect from 1 September 2021, applicants are required to submit the HSA’s acknowledgement email on the receipt of the Letter of Access from the DMF holder as documentary proof
read more...HSA Singapore has launched on 20 August 2021 a new online self-guided tool for post-approval minor variation applications (MIV) to help industry stakeholders to get quick answers on the application type, variation category
read more...Hong Kong Drug Office has published a guidance note on the registration of pharmaceutical products containing a new chemical or biological entity (NCE) in August 2021.
The aim of the document is to