The European Commission has explained how it plans to prevent Brexit from disrupting the supply of medicines in some markets, notably in Northern Ireland. The plan builds on the proposal made by the Commission in October as part of multiple rounds of negotiations with the UK.
Under parts of the Brexit deal designed to avoid a hard border with Ireland, Northern Ireland, which is part of the United Kingdom, is subject to European Union regulations. The situation has already created problems, such as when a drug became available in England, Scotland and Wales before Northern Ireland, and the end of the transitional arrangements threatens to cause shortages by erecting regulatory barriers in Irish Sea.
The proposals put forward by the Commission aim to limit barriers to trade in medicines between England, Scotland and Wales, collectively known as Great Britain, and Northern Ireland. Under the proposals, generic drugs authorized under UK national procedures will be available in Northern Ireland. UK companies can supply medicines to Northern Ireland without a manufacturing authorization or import license and without repeating batch tests carried out in Britain or the EU.
Likewise, the Commission is considering abandoning the need for manufacturers to create separate packaging for products sold in Northern Ireland. Instead, one package and one leaflet can be used to supply 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 drugs’, a topic that became an early flashpoint in discussions about the impact of Brexit in May when lung cancer patients at a Early stage in Britain had access to AstraZeneca’s Tagrisso before their counterparts in Northern Ireland.
The Commission wants to prevent this disparity in access to medicines from happening again by adopting a ‘bridging solution’ which ‘will allow any new medicine authorized in the UK to be supplied to Northern Ireland, until that the corresponding authorization is also given in the EU “. The proposed solution is in addition to the existing compassionate and emergency use mechanisms.
Thanks to the changes, which have yet 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 places this responsibility on the UK on the assumption that it will comply “essentially with EU legislation on the quality, safety and efficacy of medicines for human use”. The current transitional arrangements will remain in place until the end of 2022 to give lawmakers time to finalize and adopt the proposals.
Other parts of the proposals cover the supply of medicines to Malta, Cyprus and Ireland, countries which are not part of the UK but which, before Brexit, depended on the country for imports of pharmaceuticals. To avoid supply disruptions, the EU included the three countries in the transitional arrangements that have applied in Northern Ireland this year.
In the future, countries “will benefit from certain exemptions for a period of three years”. During this period, UK companies will be able to import medicines into countries without holding manufacturing authorizations or repeating batch tests. In the longer term, the Commission wants to find a permanent solution within the framework of the EU pharmaceutical strategy.
Press release, More
EMA lists regulatory science topics that require research to improve drug development
The European Medicines Agency (EMA) has published a list of regulatory scientific topics that require further research to “improve the development and evaluation of medicines to enable access to innovative medicines for patients”.
Through the 39-page document, the EMA lists the research topics and their associated objectives and the expected impact. For example, one topic covers best practices and standards for validating surrogates and biomarkers. EMA’s goals in this area include understanding how standards differ between regulators and payers. In doing so, EMA aims to broaden stakeholder acceptance of biomarkers and thereby facilitate drug development.
The paper presents dozens of research topics, with a subsection on catalysing the integration of science and technology into drug development alone, presenting 12 areas where further research is needed. The document has four further subsections on drugs for human use and four further subsections on veterinary drugs.
EMA Notice, Plus
MHRA publishes guidance on using real-world data in clinical studies to accelerate R&D
The UK Medicines and Health Products Regulatory Agency (MHRA) has published guidance on the use of real world data (RWD) in clinical studies to support regulatory decisions. The MHRA sees counseling as a way to help get drugs to patients earlier.
In the guide, the 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. The MHRA requires sponsors to understand the accuracy, validity, variability, reliability and provenance of RWD data and to be able to describe its limitations.
To support the assessments, the MHRA has provided a list of questions to ask sponsors, such as will the database be used as the source population for recruitment and what data quality checks are performed by the data controller. . The guide also describes four general principles and the MHRA’s approach to good clinical practice inspections and their application to RWD.
Press release, MHRA Guidance
EMA seeks feedback on consultation procedure for companion diagnostics
The EMA is seeking feedback on the draft companion diagnostic guide. The guide covers the procedural aspects of the consultation of the EMA by a notified body on companion diagnostics under the new regulations.
Notified bodies should seek scientific advice on the suitability of a companion diagnostic for use with their associated medicinal products from the EMA or a national regulatory agency before issuing a certificate of assessment of the technical documentation of the ‘EU. The guidelines define the legal basis for the requirement and provide practical recommendations.
According to the guidelines, notified bodies must provide a “letter of intent to submit” at least 3 months before the scheduled submission date. The letter should include information such as the expected submission date, the name of the affected device and the manufacturer of the device. Other parts of the project cover the data requirements, the consultation with the EMA, the post-consultation phase and the costs.
EMA is accepting comments until February 20.
EMA launches consultation on acceptability of drug names for human use
The EMA is organizing a consultation on the acceptability of the names of medicinal products for human use processed by the centralized procedure. The project updates a 2014 guideline in light of the experience gained by the Name Review Group since its inception.
The guideline covers the criteria applied when considering the acceptability of proposed names, including general requirements regarding the potential for confusion of names and specific rules related to vaccines, radiopharmaceuticals and orphan drugs.
The centerpiece of the text is an overview of the EMA procedure for checking the proposed names. The process begins with the submission of the name request by the applicant and goes through a series of review steps, before ending with a discussion of the withdrawal, expiration and reuse of names. The EMA also uses the guideline to provide a checklist for assessing objections due to name similarities.
EMA is accepting comments until March 16.
EMA adopts principles for using data standards
On December 15, the EMA Board of Directors adopted a set of principles for the use of data standards in four areas: medicines, healthcare and education data, safety and management. risk, and bids.
The document states that “until now, regulatory procedures have been primarily based on the submission of documents, leading to the assessment of the information contained in the documents rather than the assessment of the underlying data that has been used to create these documents. Regulatory processes are moving towards evaluating data rather than documents and examining the potential secondary uses of the data collected to make better regulatory decisions and improve public and animal health.
The strategy notes that the European Medicines Regulatory Network began requiring that certain submissions meet accepted data standards over a decade ago and adds that “data standards provide a set of rules or criteria for compliance which define how information (data) is to be structured, defined, formatted or exchanged.
“Standardization is an essential element in order to fully exploit the potential of (big) data and to make regulatory decisions,” the document states.
The strategy document sets out eight principles 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 standards development organizations (SDOs) under voluntary and consensus-based processes” and to “ensure that these standards data support the sharing and exchange of data, as well as ensuring data protection.
Standards for medicines would cover product information, substance information, manufacturing and quality. The guidelines stated that “developing a standardized template for all inspection data, including good manufacturing practices (GMP), would make identifying previous inspections and reports less time consuming. In addition, providing the unique identifiers of manufacturing plants will create interactions between product quality and inspections of manufacturing sites (risk-based monitoring).
EMA data standardization strategy
© 2021 Society of Regulatory Affairs Professionals.