The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) wants to know what industry and others think of how legislation and regulatory processes would have to be modified in the event of the UK not securing a deal with the EU after the UK’s exit, with no implementation period. The consultation covers no-deal proposals on medicines, clinical trials and medical devices.
MHRA notes that in the unlikely event of a no-deal scenario, it would be a stand-alone medicines and devices regulator, in charge of establishing new licensing routes, a new threshold for orphan designations, the possibility of new global partnerships and a new fee structure, among other changes.
By 1 November, MHRA is seeking answers to various questions, including on a new targeted assessment process for new applications for products containing new active substances or biosimilars which have been submitted to the EMA and received a Committee for Medicinal Products for Human Use (CHMP) positive opinion.
“The MHRA would not be seeking to repeat questions or work - it would be focusing its contribution on ensuring the quality, safety and efficacy of the product in the context of clinical use in the UK,” the consultation says. “The UK decision expects to only differ from the CHMP opinion in the situations where there is a public health concern about the risk/benefit of the product.”
Other questions deal with abridged applications, legal presence for marketing authorizations and clinical trials in the UK, pediatric investigation plans and studies, packaging and converting centrally authorized products to UK marketing authorizations.
The questions on clinical trials focus on transparency, use of designated country lists, including for legal presence and importation of investigational medicinal products and other impact assessments.
On the medical device end, MHRA is seeking answers on registration and the costs associated with registration.
And in respect to other fees, the consultation asks questions on fee waivers for orphan products, other fees for services currently conducted at the EU level and independent UK batch testing of biologics and the associated fees.
In terms of amending legislation or guidance, MHRA also offers some perspective on approaches taken toward EU directives, regulations and other legislation.
“It is proposed that UK and NI [Northern Ireland] Ministers, acting through the MHRA, would take over any tertiary legislative functions the EU currently has, including in respect of Implementing Regulations and the issuing of guidance. For example, the terms of the Pharmacovigilance Implementing Regulation will be incorporated in to domestic legislation with appropriate modifications, in particular to reflect the fact that the UK is no longer a Member State, with power to amend, revoke or modify by regulations in future,” the consultation says. “Any extant EU guidance will be preserved until the MHRA issues its own, or modifies or amends the EU guidance. Examples are: issuing the guidelines on good manufacturing practice as set out in the Good Manufacturing Directive.”