The UK medicines regulator has issued guidance explaining how companies can renew their drug marketing authorizations (MAs), initially evaluated through various EU procedures, when the transition period after Brexit comes to an end this year.
Under arrangements being put in place by the Medicines and Healthcare products Regulatory Agency, all medicines approved under the EU’s centrallized procedure will be automatically converted into UK MAs effective in Great Britain. To support the grandfathering process, the MHRA explained that it will issue a UK MA number for all centrally authorized products (CAPs) on 1 January 2021, unless a company chooses to opt out of the conversion process for all or some of their CAPs.
For the purpose of renewals, the MHRA explained that the converted EU MAs will be “treated as if they were granted on the date on which the corresponding EU MA was granted,” which means they will have the same renewal date in the UK as in the EU.
To support the ongoing oversight of converted EU MAs by the MHRA, companies will have to submit essential baseline data in the form of an initiating electronic Common Technical Document (eCTD) sequence together with certain other related MA-specific information for each converted EU MA.
The MHRA explained that, in general, it will not consider renewals to converted EU MAs before at least a minimal initiating sequence and related documentation (a “data submission package”) has been received. It said that renewal applications may be included with the data submission package as separate eCTD sequences in line with the normal national MA renewal process, but these will only be considered after the baseline data is processed.
In exceptional circumstances, however, the agency may consider a renewal for either a converted EU MA or a converted conditional EU MA before the data package is submitted (in the absence of a minimal or fully initiating sequence) where:
- The renewal is necessary on urgent safety grounds.
- The renewal is necessary in order to maintain supplies of a particular medicinal product to patients in Great Britain.
- There are other necessary or beneficial reasons for considering the renewal in advance of receipt of the baseline information.
Companies who believe that these conditions may apply to their products are being advised to seek agreement from the MHRA and to discuss how to proceed.
Companies will have to pay £9,682 ($12,800) for the first renewal of a product containing a new active ingredient at the time of authorization and £747 for related applications made at the same time as the first renewal. There will be no fees for subsequent MA renewals or for renewing conditional MAs, the agency said.
The renewal of Great Britain and converted EU MAs granted conditional approval will be in accordance with new regulation 66B of the Human Medicines Regulations 2012. Regulation 66B states, among other things, that the company seeking renewal of the conditional MA should provide an “interim report on the fulfilment of the obligations to which the conditional marketing authorisation is subject.” (Also see "UK To Have Own Conditional Drug Approval Scheme in 2021" - Pink Sheet, 3 Sep, 2020.)
Renewal Applications Made To EMA
In a separate guideline on managing lifecycle changes to converted EU MAs, the MHRA has explained how it intends to deal with cases where companies that hold converted MAs have applied to the European Medicines Agency for their EU MA to be renewed before 1 January 2021 but no final decision has been made by that date. It has developed separate provisions to deal with the following cases:
- Where, before 1 January 2021, the EMA’s human medicines evaluation committee, the CHMP, has given a positive final opinion and the UK has concurred.
- If, before 1 January 2021, the renewal application has not reached CHMP opinion and is in clock-stop following a request for further information.
- If, before 1 January 2021, the renewal application has not reached CHMP opinion and is before the clock stop stage.
- Where, before 1 January 2021, the CHMP has given a negative final opinion or given a positive final opinion but the UK has recorded a divergent opinion.
For renewal of MAs granted through the EU mutual recognition or decentralized procedures (MRP/DCP) that do not get a decision before 1 January 2021, the MHRA clarified that companies will not have resubmit these.
If a final renewal decision has been made, but has not been processed in the UK before the January date, the MHRA said it would implement the agreed outcome. “Where a final decision has not been made, the MHRA will ensure that the renewal process is concluded and processed by the appropriate route.”