Our latest update from the industry demonstrates the uncertainty around BREXIT. Christina Hägglund, Quality Assurance Manager, gathers together everything you need to know from around the globe.
Redistribution of UK’s Product Portfolio
Ahead of Brexit, the EU Member States and the European Medicines Agency (EMA) have reallocated the medicines for which the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is currently rapporteur or co-rapporteur. It ensures an optimised, sustainable and robust allocation of the workload across the European regulatory network, allowing national Competent Authorities to participate in EMA activities according to their capacity and expertise. You can read more in the following links:
Marketing Authorisation Holders (MAHs) Delaying Brexit Preparations
In January 2018, the EMA issued a questions and answers document designed to encourage MAHs of centrally authorised medicinal products to prepare for the UK’s exit from the EU. The European Commission is concerned however that many MAHs are delaying critical regulatory actions, including transferring their marketing authorisations which could lead to an interruption in medicines supplies. Full details in the link below:
EMA Ensures Transparency in its Relocation to Amsterdam
The EMA’s critical role in safeguarding health across the EU means that it is committed to providing full public visibility over its relocation project. Interested parties have access to ‘live’ information on EMA’s preparations for two sequential moves to new premises in Amsterdam. This tracking tool will allow all parties to follow the progress. Read more here: https://www.ema.europa.eu/docs/en_GB/document_library/Other/2018/03/WC500244941.pdf
Increasing Focus on Patient Engagement in Drug Development
Recent announcements indicate that regulators and representative bodies, as well as sponsors, are keen to engage more productively with patients. Sponsors in particular are beginning to understand how proactively engaging with patients and learning more about the day-to-day impact of living with specific diseases – as well as patients’ willingness to accept certain risks in return for access to promising new treatments – may increase the likelihood of regulatory and commercial success. Full details in the following links:
FDA to Enhance Patient Perspective in Drug Development and Review
The FDA has updated its implementation plan for enhancing benefit-risk assessment and communication in the drug review process.
Benefit-risk assessment is the fundamental tool for ensuring that medical products are safe, effective and meet patients’ needs. It is clear however that patients’ perceptions of the benefits and risks of different treatment options can vary for a huge number of reasons, from the stage of the disease, the age of onset and the available alternative therapies to whether a novel therapy improves a patient’s ability to function normally, slows the rate of disease progression or impacts other aspects of quality of life. To address these realities, the FDA wants to work in close partnership with patients and incorporate their experiences into regulatory benefit-risk assessments. Read more here:
SHARING DATA AND INFORMATION
New Principles and Recommendation for Sharing and Reusing Trial Data
The International Committee of Medical Journal Editors (ICMJE) believes that there is an ethical obligation to responsibly share data generated during clinical trials, on the basis that trial subjects have put themselves at risk. Data sharing generally remains more of a concept than a reality however. The British Medical Journal (BMJ) has now published an open access article describing principles and practical recommendations for sharing data from clinical trials. Although focused on non-commercial studies, the article has relevance to those working within a commercial framework. Full details: https://bmjopen.bmj.com/content/7/12/e018647
International Collaboration Leads to Increased Oversight of Active Pharmaceutical Ingredient (API) Manufacturing
The EU has various mutual recognition agreements in place with third country authorities to enable data from such countries to be accepted. One such agreement is with the USA and this allows for mutual recognition of GMP inspections and batch certification of medicines.
The EMA and several international partners are working to improve the oversight of API manufacturers worldwide. This international collaboration allows the EMA; EU national authorities in France, Denmark, Ireland, Italy and the UK; the European Directorate for the Quality of Medicines; the FDA; Australia’s Therapeutic Goods Administration; Health Canada; the Japanese Ministry of Health, Labour and Welfare, and Pharmaceuticals and Medical Devices Agency; and the World Health Organization to share information on Good Manufacturing Practice inspections of API manufacturers located outside the participating countries. Follow the links for more details:
- FDA Seeks Comments on Technical Standards for Electronic Submissions
- The FDA adopts ICH E11 Addendum – Clinical Investigation of Medicinal Products in the Paediatric Population
- FDA finalises new guidance on clinical trial imaging endpoints
- FDA issues new draft guidance on clinical trials in pregnant women
- FDA releases final guidance on Special Protocol Assessment (SPA) Program
- FDA’s Medical Device Safety Action Plan to enhance patient protection
EU – General Data Protection Regulation (GDPR)
The GDPR replaces the Data Protection Directive 95/46/EC and aims to harmonise data protection across Europe. For those working in clinical research, it details the principles that apply to data controllers and to the use of patient data. A GDPR Portal has been set up as an educational resource of the main elements of the GDPR. Links below:
EU – Clinical Trials Regulation Update
At the EMA’s Management Board meeting in London on 15 March 2018, an update on the development of the EU portal and database was given.
The first item (release 0.6) due under the revised plan has been received and has met the acceptance criteria. Release 0.7 should be available for audit (as required by Article 82 of the Clinical Trial Regulation) in early 2019. More precise information on timelines will be communicated after the audit.
EU – Updated Guidance of the Clinical Development of Vaccines
The EU has revised its guideline on the clinical evaluation of vaccines for infectious diseases.
Drug Resistant Infections
The 2018 Antimicrobial Resistance (AMR) Benchmark is now available online. It is the first report to assess how pharmaceutical companies are tackling rising rates of drug-resistant infections. The Benchmark finds evidence of good practice in multiple areas, although it highlights the need to expand this to more products. The pipelines described in the report include 175 antimicrobial medicines targeting pathogens considered as the biggest AMR threats. Of those, 40 drug candidates – including 28 antibiotics – are in late-stage clinical development. However, only two are supported by plans to ensure that the successful candidate is both accessible and used wisely.
UK – Clinical Trial Agreement Template
The Integrated Research Application System has issued revised versions of the Model Clinical Trial Agreement (mCTA). The new mCTA came into force on 01 March 2018 and replaces the previous version from 2011. It allows a single model contract for commercial research and development to be used in England, Scotland, Wales and Northern Ireland, cutting out unnecessary administration for running the same study in National Health Service (NHS) or Health and Social Care (HSC) hospitals across the UK. Although the revisions are not extensive, the new versions reflect current practice and regulations and are available for immediate use.