The Human Medicines and Medical Devices (Amendment etc.) (EU exit) Regulations 2019 was laid in UK parliament on the 24th July 2019.
The EMA recently shared the highlights of patient, consumer, healthcare professional and academia involvement in our activities in 2018 with the RQA.
Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 July 2019
EMA welcomes the European Ombudsman’s recognition of the value and need for scientific advice and her recommendations are in line with EMA’s ongoing initiatives to further increase transparency.
The Government has announced the decision to invest around £16 million in various ‘life-saving’ medical advances, including improved diagnosis and treatment for cancer and heart disease.
With the recognition by the US Food and Drug Administration (FDA) of Slovakia, the European Union and the United States have now fully implemented the mutual recognition agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective territories.....
Updated Version of the Clinical Trials Regulation Questions & Answers Paper
Today, the U.S. Food and Drug Administration (FDA) issued a final guidance for industry entitled Risk Evaluation and Mitigation Strategies: Modifications and Revisions.
The United Kingdom submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union.
The MHRA opened a three-month public consultation (until August 31, 2019) on its plans to apply analytical quality by design (AQbD) principles to its pharmacopoeia.