In this week’s news, MHRA calls for no-deal input, Ireland outlines pharma plans and more…
MHRA calls for industry input on post-Brexit regulatory changes
The Government has asked for input on what legislative and regulatory changes would be needed in the event the UK crashes out of the EU without a trade deal.
The Medicines and Healthcare products Regulatory Agency (MHRA) called for input last week, less than 180 days before the UK is due to withdraw from the bloc.
The regulator said it wants feedback on four different laws, specifically the Medicines for Human Use (Clinical Trials) Regulations 2004, the Medical Devices Regulations 2002 and the Human Medicines Regulations 2012 (HMRs) and the Medicines (Products for Human Use) (Fees) Regulations 2016.
It also confirmed that, in the event of a no-deal Brexit, it will be a “stand-alone medicines and medical devices regulator, taking any decisions and carrying out any functions which are currently taken or carried out at EU-level.”
Industry response: ABPI welcomes ‘no-deal’ prep but still favours agreement
UK industry group, the Association of the British Pharmaceutical Industry (APBI) said it would respond to the consultation in due course.
According to ABPI Deputy Chief Scientific Officer Sheuli Porkess said, “It is important that the UK puts plans in place for a ‘no deal’ Brexit. Pharmaceutical companies continue to plan for all possible outcomes from the negotiations and we will continue to work closely with the Government on their plans.
“But we have been very clear that the best way to protect patients and public health in the UK and in the EU is to agree future cooperation between the MHRA and the EMA on the regulation of medicines.
Concerns about Brexit’s negative impact on EU
Experts at a drug industry even in Brussels have raised concerns about the impact Brexit will have on Europe as an investment destination.
According to a report in Euractiv, experts who discussed the UK departure from the EU at Biotech Week in Brussels were downbeat, arguing that the continent may lose out to regions where the regulatory burden is lower.
Ireland outlines plan for future of pharma industry
A group representing the drug sector in Ireland has outlined its ‘manifesto’ for the life science and health care industry with an eye on the European elections next year.
The document – available here – touches on a range of subjects, from improving access to medicine to increasing production capacity in Ireland, via fostering the development of public-private partnerships.
Also in the news
Momenta has announced plans to cease development of biosimilars and focus on the creation of innovative biopharmaceuticals. Read more at the CenterforBiosiimilars.
Biopharmadive took a look at how continuous manufacturing is changing the contract manufacturing industry.
The Medicine Maker reviewed “Made in China 2025,” focusing on the country’s efforts to modernize its manufacturing sector, including the drug and API industries.
GSK has updated its plans for its manufacturing plant in Ulverston, Cumbria. Read more at FiercePharma.