• Australia: Proposed changes to the Essential Principles for safety and performance

• Australia: Proposed changes to the requirements for systems and procedure packs

• Australia: Feedback sought on the regulation of certain self-testing IVDs in Australia

• ...

• China : NMPA No. 2019/34 Issuance of Provision n Drug Quality Inspection and and Testing

• EU/US : EMA/FDA Analysis Shows High Degree of Alignment in Marketing Application Decisions Between EU and US.

• South Korea :  Five-year Master Plan for Clinical T...

• China - CFDA Announcement No. 2017/187: Announcement on Cancellation of Drug Protection Fees, Certification Fees, Import / Export Licences Fees of Narcotic and Psychotropic Drugs

• Philippines - FDA Circular No. 2012-007-A: Amending FDA Circular No. 2012-007: Re...

• Australia - Procedure for Priority Review / Accelerated Approval

• China - NMPA Announcement 2019/10: Adjusting Classification of 12 Types of Drugs

• South Korea - Procedure for Applying for a Manufacturing / Wholesale Licence

• Taiwan - MOHW Announcement...

Taiwan FDA is currently seeking public feedback on three new regulations in cosmetic products.

The Authority proposing draft Regulations for the Inspection and Examination of Imported Cosmetics, including requirements for the methods, techniques, items and scope of samp...

• Australia - Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2018

• Brazil - Questions and Answers: Resolution RDC 242/2018 on Registration of Specific Medicinal Products

• Canada - Form: Post-Notice of Compliance Changes: Level III

• Chin...

• US: Minimal Manipulation and Homologous Use Products

• US: Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients

• US: De Novo Classification Process (Evaluation of Automatic Class III Designation

• US: Medical Device Develo...