- Dec 4, 2019
Europe - Nov/Dec 2019
EU: Commission Implementing Decision (EU) 2019/1396 on the designation of expert panels EU: Industry expresses concerns about proposed...
- Aug 30, 2019
Drugs - Aug 2019
China : NMPA No. 2019/34 Issuance of Provision n Drug Quality Inspection and and Testing EU/US : EMA/FDA Analysis Shows High Degree of...
- Jun 28, 2019
Europe - Jun 2019
Czech Republic: Form released for accessing online reimbursement system EU: Corrigenda published to Regulations 2017/745 and 2017/746 EU:...
- Jun 28, 2019
Drugs - Jun 2019
China - CFDA Announcement No. 2017/187: Announcement on Cancellation of Drug Protection Fees, Certification Fees, Import / Export...
- Mar 29, 2019
Europe - Mar 2019
EU: More advisory documents issued to support implementation of MDR and IVDR EU: Manual on borderline and classification issues updated...
- Mar 29, 2019
Drugs - Mar 2019
Australia - Procedure for Priority Review / Accelerated Approval China - NMPA Announcement 2019/10: Adjusting Classification of 12 Types...
- Mar 29, 2019
UK regulator provides further ‘no deal’ Brexit guidance for medical devices regulation
On 26 February, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published further guidance setting out the...
- Mar 28, 2019
Australia TGA Plans for Brexit
The exit of the United Kingdom (UK) from the European Union (EU) will cause implications to the medical industry in Australia....
- Nov 5, 2018
Europe - Dec 2018
EU: UDI guidance documents developed by the MDCG to support implementation of MDR EU: Basic guidance issued for manufacturers on...
- Nov 5, 2018
Drug - Dec 2018
Australia - Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2018 Brazil - Questions and Answers: Resolution RDC...