The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the introduction of new international recognitions routes for the approval of medicines that are already authorised in Australia, Canada, the...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related clinical trials that would need to be...more
10/5/2018
/ Consultation ,
EU ,
European Medicines Agency (EMA) ,
Imports ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Member State ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agencies ,
Regulatory Oversight ,
UK ,
UK Brexit
On 23 August 2018, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), the network of the National Competent Authorities in the European Economic Area (EEA), published the work programme of their...more
9/6/2018
/ Biotechnology ,
EU ,
European Economic Area (EEA) ,
European Medicines Agency (EMA) ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Standards ,
Supply Chain ,
UK ,
UK Brexit ,
Veterinary Products
MPs have voted to accept an amendment to the Trade Bill that requires the UK Government to make continued UK participation in the EU/EEA medicines regulatory network, including the European Medicines Agency (EMA), a...more
The White Paper appears largely positive for the life sciences industry, incorporating many of the key asks from the industry across its priority areas of regulation, trade, people and innovation....more
On 19 June 2018, the European Medicines Agency (EMA) published updates to its Brexit Q&A document for human and veterinary medicines authorised via the centralised procedure and to its practical procedural guidance on making...more
6/29/2018
/ Animal Drugs ,
EU ,
European Medicines Agency (EMA) ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Standards ,
UK ,
UK Brexit
The UK Government has published a response to the recommendations set out in the Health and Social Care Committee’s Report dated 21 March 2018 on “Brexit: medicines, medical devices and substance of human origin”, which...more
The UK House of Commons Health and Social Care Committee has published the findings of its six-month long investigation into the impact of Brexit on medicines, medical devices and substances of human origin. ...more
3/28/2018
/ Biosimilars ,
Biotechnology ,
EU ,
European Medicines Agency (EMA) ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Member State ,
Pharmaceutical Industry ,
Referendums ,
Regulatory Oversight ,
UK ,
UK Brexit
On the same day as the European Council voted to move the European Medicines Agency (EMA) from London to Amsterdam, the UK Parliament issued a briefing paper on Brexit and medicines regulation. ...more
11/22/2017
/ EU ,
European Medicines Agency (EMA) ,
Imports ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Member State ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Referendums ,
Regulatory Agencies ,
Regulatory Oversight ,
UK ,
UK Brexit
With the negotiations for the UK’s withdrawal from the EU formally under way, the UK healthcare sector is calling on the UK Government to make patient safety and access to medicines a priority in negotiations – and it appears...more