RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > 2021 > 12 > Euro Roundup: Commission acts to stop Brexit from disrupting supply of medicines

Euro Roundup: Commission acts to stop Brexit from disrupting supply of medicines

Posted 23 December 2021 | By Nick Paul TaylorJoanne S. Eglovitch 

Euro Roundup: Commission acts to stop Brexit from disrupting supply of medicines

The European Commission has set out how it plans to stop Brexit from disrupting the supply of drugs in certain markets, most notably Northern Ireland. The plan builds on the proposal the Commission made in October as part of the multiple rounds of negotiations with the United Kingdom.
Under parts of the Brexit agreement designed to avoid a hard border on Ireland, Northern Ireland, which is part of the UK, is subject to European Union regulations. The situation has already created issues, such as when a drug became available in England, Scotland and Wales before Northern Ireland, and the end of transitional arrangements threatens to cause shortages by erecting regulatory barriers in the Irish Sea.
The proposals put forward by the Commission are intended to limit the barriers to the trade in medicines between England, Scotland and Wales, known collectively as Great Britain, and Northern Ireland. Under the proposals, generic medicines authorized under national UK procedures will be available in Northern Ireland. Companies in Great Britain can supply medicines to Northern Ireland without manufacturing authorization or import licenses and without repeating batch testing done in Great Britain or the EU.
Similarly, the Commission is planning to waive the need for manufacturers to create separate packaging of products sold in Northern Ireland. Rather, a single pack and leaflet can be used when supplying all UK markets. All regulatory functions can remain in the UK if they are currently located there.
The proposals also cover the availability of “innovative life-saving medicines,” a topic that became an early flashpoint in discussions of the impact of Brexit in May when early-stage lung cancer patients in Great Britain gained access to AstraZeneca’s Tagrisso before their counterparts in Northern Ireland.
The Commission wants to stop that drug access disparity from happening again by adopting a “bridging solution” that “will allow any new medicine authorized in the UK to be supplied to Northern Ireland, until the relevant authorization is also given in the EU.” The proposed solution is in addition to existing compassionate and emergency use mechanisms.
Through the changes, which still need to be adopted by the European Parliament and the Council, the EU will give the UK sole responsibility for authorizing medicines in Northern Ireland. The EU is giving the UK that responsibility on the assumption it will comply “substantively with EU law on quality, safety and efficacy of human medicines.” The current transitional arrangements will remain in place until the end of 2022 to give legislators time to finalize and adopt the proposals.
Other parts of the proposals cover the supply of medicines in Malta, Cyprus and Ireland, countries that are not part of the UK but before Brexit were reliant on the country for imports of pharmaceuticals. To prevent supply disruption, the EU included the three countries in the transitional arrangements that have applied in Northern Ireland this year.
Going forward, the countries “will benefit from certain derogations for a three-year period.” Over that period, UK companies will be able to import medicines into the countries without holding manufacturing authorizations or repeating batch testing. In the longer term, the Commission wants to find a permanent solution as part of the EU's Pharmaceutical Strategy.
Press Release, More
EMA lists regulatory science topics that need research to improve drug development
The European Medicines Agency (EMA) has published a list of regulatory science topics that need further research to “improve medicine development and evaluation to enable access to innovative medicines for patients.”
Across the 39-page document, EMA lists research topics and their associated objectives and expected impact. For example, one topic covers best practices and standards for validation of surrogate endpoints and biomarkers. EMA’s objectives in that area include gaining an understanding of how standards differ among regulators and payers. In doing so, EMA aims to widen stakeholder acceptance of biomarkers and thereby facilitate drug development.
The document features tens of research topics, with a subsection on catalyzing the integration of science and technology in medicines development alone featuring 12 areas in which more research is needed. The document features four other subsections on human medicines and a further four subsections on veterinary medicines.
EMA Notice, More
MHRA posts guidance on the use of real-world data in clinical studies to accelerate R&D
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on the use of real-world data (RWD) in clinical studies to support regulatory decisions. MHRA sees the guidance as a way to help get medicines to patients sooner.
In the guidance, MHRA provides some introductory advice, explaining the need to demonstrate that the data source is good enough for the intended use, before focusing its discussion on data quality. MHRA is asking sponsors to understand the accuracy, validity, variability, reliability and provenance of RWD data and to be able to describe its limitations.
To support the evaluations, MHRA has provided a list of questions for sponsors to ask, such as will the database be used as the source population for recruitment and what data quality checks are undertaken by the data controller. The guidance also describes four general principles and MHRA’s approach to good clinical practice inspections and their application to RWD.
Press Release, MHRA Guidance
EMA seeks feedback on the consultation procedure for companion diagnostics
EMA is seeking feedback on draft companion diagnostic guidance. The guidance covers the procedural aspects for the consultation to EMA by a notified body on companion diagnostics under the incoming regulations.
Notified bodies need to seek scientific opinions on the suitability of a companion diagnostic for use with their associated medicinal products from EMA or a national regulatory agency before issuing an EU  technical documentation assessment certificate. The guidance sets out the legal basis for the requirement and makes practical recommendations.
Under the guidance, notified bodies are expected to provide an “intention to submit letter” at least 3 months before the planned date of submission. The letter should include information such as the date of expected submission, the name of the concerned device and the device manufacturer. Other parts of the draft cover data requirements, consultation with EMA, the post-consultation phase and fees.
EMA is accepting feedback until 20 February.
Draft Guidance
EMA starts consultation on the acceptability of names for human medicinal products
EMA is holding a consultation on the acceptability of names for human medicinal products processed through the centralized procedure. The draft updates a 2014 guideline in light of experience gathered by the Name Review Group since its creation.
The guideline covers the criteria applied when reviewing the acceptability of proposed names, including general requirements regarding the potential for names to cause confusion and specific rules related to vaccines, radiopharmaceuticals and orphan medicinal products.
The centerpiece of the text is an overview of the EMA procedure for checking proposed names. The procedure starts with the submission of the name request by the applicant and runs through a series of review steps, before concluding with a discussion of the withdrawal, expiry and re-use of names. EMA is also using the guideline to provide a checklist for assessment of objections because of name similarities.
EMA is accepting feedback until 16 March.
Draft Guideline
EMA adopts principles for using data standards
The EMA Management Board on 15 December adopted a set of principles for using data standards in four areas: medicinal products, healthcare and study data, safety and risk management, and submissions.
The document states that “until now regulatory procedures have been mainly document submission based leading to the assessment of information contained in documents rather than assessing the underlying data that were used to create those documents. The regulatory processes are shifting to assessing data rather than documents and looking at the potential secondary uses of the data collected to drive better regulatory decisions and improve public and animal health.”
The strategy notes that the European Medicines Regulatory Network started requiring certain submissions be compliant with recognized data standards over a decade ago and adds that “data standards provide a set of rules or conformance criteria that set out how information (data) should be structured, defined, formatted, or exchanged.”
“Standardisation is a critical element for realising the full potential of (big) data and driving regulatory decisions,” the document states.
The strategy document lays out eight principles intended to guide data standardization efforts and the adoption of data standards across the European Medicines Regulatory Network.
The eight principles include calls to “ensure the use of high-quality data standards developed by accredited standard development organizations (SDOs) in accordance with voluntary and consensus-based processes,” and to “ensure that such data standards support data sharing and exchange, as well as ensure protection of the data.”
Standards for medicinal products would cover product information, substance information and manufacturing and quality. The guidance said that “developing a standardized template for all inspections data, including good manufacturing practices (GMP), would make the identification of previous inspections and reports less time consuming. Moreover, providing the unique identifiers of manufacturing facilities will enable the creation of interactions between product quality and inspections of manufacturing sites (risk-based tracking).
EMA data standardisation strategy


© 2022 Regulatory Affairs Professionals Society.