pharmaceutical

PIC/S: Revised PIC/S GMP Guide on Manufacture of Sterile Products (Lyophilization - w.e.f 25 August 2024)

Annex 1 of the PIC/S Good Manufacturing Practise (GMP) Guide on the manufacture of sterile products has been revised and published. The...

India: Requirement of Toxicity Studies for New Drugs, SNDs, and FDCs

On the 29th of July 2024, the Central Drugs Standard Control Organization (CDSCO) released new circular on the requirement for toxicity...

Hong Kong: New Screening Protocol Introduced for Registration Application of Pharmaceutical Products/Substances (w.e.f 1 July 2024)

The Pharmacy and Poisons Board of Hong Kong (“the Board”) announced that the Refuse-to-File (“RTF”) Mechanism will be enforced in the...

Hong Kong: Medical Gases Endorsed as Pharmaceutical Products (w.e.f 14 June 2026)

Overall responses from full and thorough jurisdictions based on the current situation in Hong Kong and public consultation led by the...

India: New Self-Declaration Requirement Implemented for Pharmaceuticals & Medical Device Associations (d.d 30 June 2024)

On the 28th and 30th of May 2024, the Department of Pharmaceuticals of India released 2 Standing Orders regarding the new...

Australia: TGA Adopts PIC/S Guide to GMP Version 16: Manufacturing Principles for Medicines, APIs & Sunscreens (w.e.f 3 September 2024)

On 3 June 2024, the Therapeutic Goods Administration (TGA) amended its Therapeutic Goods (Manufacturing Principles) Determination...

China: Optimization of Registration Application for Transferring Overseas-Produced Drugs into Domestic Production

As part of the initiative to boost foreign investments in the pharmaceutical industry and improve high-quality drug developments and...