Consolidated List of MHRA Guidelines and Updates Published in 2022
Period: January 2022 to December 2022
The MHRA (Medicines and Healthcare products Regulatory Agency) is a UK government agency responsible for ensuring that medicines and medical devices meet safety standards. The MHRA publishes guidelines on a range of topics related to the pharmaceutical industry, including good manufacturing practice (GMP), clinical trials, and pharmacovigilance. These guidelines can be helpful to pharmaceutical industry professionals in a number of ways:
- They provide guidance on how to comply with regulatory requirements: The MHRA guidelines outline the requirements that must be met in order to obtain and maintain a license to manufacture or sell pharmaceutical products in the UK.
- They can help to ensure the safety and effectiveness of products: The guidelines provide recommendations on how to manufacture, test, and distribute pharmaceutical products in a way that ensures their safety and efficacy.
- They can facilitate the development of new treatments: The guidelines provide guidance on how to conduct clinical trials, which is essential for the development of new treatments.
- They can help to improve the quality of products: The guidelines provide recommendations on good manufacturing practices (GMP), which can help to ensure the quality and consistency of pharmaceutical products.
Overall, the MHRA guidelines are an important resource for pharmaceutical industry professionals, as they provide guidance on how to meet regulatory requirements, ensure the safety and effectiveness of products, and improve the quality of the products they manufacture and sell.
Following are the Consolidated List of MHRA Guidelines published in the year 2022.
| Guidance | Date of Update | Details of update and Link |
| Guidance for regulating medical devices in the UK | January 01, 2022 | The purpose of the guidance updated was to reflect changes to medical device regulatory requirements that will take effect from January 1, 2022. It covers what one should do to deploy a medical device in the Great Britain, European Union (EU) markets, and Northern Ireland. Source: Link |
| Statistics regarding expected time taken to process and grant a marketing authorisation or a variation to a marketing authorisation | January 04, 2022 | Source: Link |
| MHRA updated various documents and guidance from January 1, 2022 to January 7, 2022 | January 1, 2022 to January 7, 2022 | 1. Great Britain Marketing Authorisations (MAs) for Centrally Authorised Products (CAPs) 2. Clinical trials for medicines: apply for authorisation in the UK 3. Apply for the early access to medicines scheme (EAMS) 4. Innovative Licensing and Access Pathway 5. Coronavirus (COVID-19) vaccines adverse reactions 6. Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients 7. Importing medicines into Northern Ireland 8. Regulatory approval of Vaxzevria (previously COVID-19 Vaccine AstraZeneca) 9. Notify the MHRA about a clinical investigation for a medical device 10. Medicines: licensing time-based performance measures 11. Human and veterinary medicines: register of licensed wholesale distribution sites 12. Medicines: new manufacturing and wholesale dealer licences 13. Register of brokers authorised to deal in human medicines 14. Medicines: terminated and cancelled manufacturing and wholesale dealer licences 15. Regulating medical devices in the UK 16. Register medical devices to place on the market |
| MHRA’s new proposals for the future clinical trial legislation | January 17, 2022 | The Medicines and Healthcare products Regulatory Agency (MHRA) has invited to contribute their views on far-reaching proposed revisions to the clinical trial legislation in the UK. As per MHRA, rhe objective of this proposal is to “improve and strengthen the UK clinical trials legislation to make the UK the best place to research and develop safe and innovative medicines”. Source: Link 1 Link 2 |
| Risk-Adapted Approach to clinical trials and Risk Assessments | January 28, 2022 | Through this guideline, the agency is directing to the sponsors to carryout and record a formal risk assessment as early as possible to understand that the clinical studies falls under the Clinical Trials legislation, categorization of trial and possibility of barriers in execution of the studies. The topics covered under guidance are: • When and how to undertake the risk assessment • Retention and distribution of the Risk Assessment • Revision of the Risk Assessment • Investigator site staff experience and training in clinical trials/GCP etc. • Submission of risk assessment to the MHRA and the REC • Benefits of the risk assessment process • GCP Inspections • Examples of risk assessments Source: Link |
| MHRA has published article on MHRA blog on “New year, new standards for investigational medicines” | February 10, 2022 | Recently, Clinical Trial regulation came into effect in the EU, “the Commission guidelines on good manufacturing practice for investigational medicinal products for human use” (It is revised Annex 13 of EU GMP). Even though the EU is EU CTR will not be applicable for UK, the UK requirements will not get changed until completion of consultation on legislation for new proposals with respect to UK clinical trial. As per the blog, UK will be aligned with the globally harmonised standards of PIC/S and the EU, including requirements for the Qualified Person. Source: Link |
| MHRA Good Practice Symposia Week (7 to 11 March 2022) | February 24, 2022 | As per the website, MHRA will be hosting series of Symposia on Good Practice. It will be live stream and online event. This can be accessed by registered delegates as recordings after the symposium. The purpose of recording is to prevent difficult situation because of different time zone of attendees and people may not be able to watch completely in real time. You can find more about this at https://MHRA-good-practice-symposia.co.uk/home. Source: Link |
| MHRA has published blog “Compliance Monitor process (Part 1) – An introduction” on its website. | March 11, 2022 | This is the 1st part of blog series on the Compliance Monitor process. This process will be piloted by the MHRA from April 2022. Potential benefits of the program are: The company will benefit from being able to concentrate on the delivery of the required improvements without having to divert their resources to manage MHRA supervision inspections to assess compliance remediation activities. Under this pilot program, the GMP and GDP remediation will be supervised by eligible consultants that will act as Compliance Monitors. The potential benefits are: • Agency resources can concentrate on routine risk-based inspection programme. • Minimize potential shortages medicines supply using risk-based supervision and monitoring. Source: Link |
| Metformin in pregnancy shows no safety concerns | March 15, 2022 | As per the studies, it has been understood that there are no safety concerns relating to the use of metformin during pregnancy. Now, the metformin can be considered for use during pregnancy as well is during periconceptional phase. This can be an addition or an alternative to insulin (when clinically needed). Source: Link |
| MHRA has granted a list of herbal medicines currently holding a traditional herbal registration | March 25, 2022 | Source: Link |
| MHRA updated “Medicines: get scientific advice from MHRA” | March 25, 2022 | Source: Link |
| MHRA updated on “Medicines: reclassify your product – Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification” | April 4, 2022 | Source: Link |
| Press release: “The MHRA are seeking views to strengthen conflicts of interest policy for independent advisors” | April 12, 2022 | MHRA has invited UK public and stakeholders to have their view on how the MHRA manages the conflicts of interest for experts those are independent and how involvement of patients in expert committee meetings to ensure transparency and consistency. Source: Link |
| MHRA is open for consultation on a new Code of Practice for the Expert Advisory Committees | April 12, 2022 | MHRA is consulting on a proposal sets to strengthen and improve the Code of Practice for experts. Where these experts are involved in giving advice that can be used for decisions about the regulation of medical devices and medicines. The objective of this guidance is to ensure that experts giving the advice and opinion as an independent entity and impartial, and process is robust and clear enough to to manage conflicts of interest. This consultation closes at 11:45pm on May 24, 2022. Source: Link |
| News from MHRA: “Sunset clause: request for public health exemption” | April 14, 2022 | Source: Link |
| MHRA published Guidance on “Innovative Licensing and Access Pathway” that supports innovative approaches to the timely, safe, and efficient medicine development to improve patient access. | April 29, 2022 | The ILAP aims to speed up the time to market and provide patient access to medicines. It covers biological medicines, new chemical entities, repurposed medicines, and new indications. The Innovative Licensing and Access Pathway is open to non-commercial and commercial developers of medicines within the UK or global. Note: ILAP – Innovative Licensing and Access Pathway Source: Link |
| Compliance Monitor (CM) Overview and Application Process | April 29, 2022 | As per the MHRA website, they are going to run a pilot scheme to monitor organizations that fail to comply with GMP and GDP and are referred to the IAG post inspection and compliance escalation process being initiated for them. (Note: IAG – Inspection Action Group) The process will support the agency in focusing resources on completion of the routine risk-based inspection for ensuring patient safety. During this process IAG will monitor and support the implementation of an agreed Compliance Protocol. As per the details provided on the website, “A company offered the CM oversight route may choose not to accept this and can continue with the routine IAG process”. This process from the CM will help the company to focus on remediation of the CAPA and augment the oversight of the MHRA. Source: Link |
| Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland | May 04, 2022 | The guidance is updated for “Register of Written Confirmations for UK active substance manufacturers”. Source: Link |
| MHRA blog publishes “Compliance Monitor Process (Part 2) – CM role and application process” | May 10, 2022 | On May 10, 2022 second part a two-part blog series on the CM Process that was piloted by the MHRA from April 2022. The second part of the blog gives information on the application process and CM role. Source: Link |
| Guidance on handling of Decentralised and Mutual Recognition Procedures which are approved or pending | June 24, 2022 | MHRA has updated the guidance to include Section ‘Guidance for The Conversion of PLGB or PLNI licences to PL’ Source: Link |
| MHRA Published Government response to consultation on the future regulation of medical devices in the United Kingdom | June 26, 2022 | MHRA had consulted on required changes to the regulatory framework for medical devices in the UK between September and November 2021. The objective of the proposal was to get opinion on developing a future legislation for medical devices which aiming improved patient safety, transparency, • close alignment with international best practice, and • more flexible, responsive and proportionate regulation of medical devices Source: Link |
| Update from MHRA: Good laboratory practice (GLP) for safety tests on chemicals – Updated PDF – Current Members of the UK GLP compliance programme | June 28, 2022 | Source: Link |
| MHRA is decommissioning of Suspected Unexpected Serious Adverse Drug Reactions (SUSARs) | Date of news: August 3, 2022 | The MHRA is decommissioning the eSUSAR website to support Individual Case Safety Reports (ICSR) Submissions; providing users a more stringent, robust, and transparent process of SUSARs from Clinical Trials of Investigational Medicinal Products. Source: Link |
| Blog published by MHRA “Innovation, Quality & Transparency – a Compliance Team 1 Perspective” | August 23, 2022 | Source: Link |
| MHRA seeks Consultation on proposals for changes to the Medicines and Healthcare products Regulatory Agency’s statutory fees | August 31, 2022 | This consultation’s goal is to gather input from interested parties on proposed changes to the Medicines and Healthcare Products Regulatory Agency’s statutory fees (MHRA). Three categories can be used to group the suggested changes: A 10% increase in indexation for all statutory fees 61 substantially underrecovering fees will receive a further increase in order to achieve cost recovery. Since the recent price revisions in 2016/2017 for medications and 2017/2018 for medical devices, there have been the introduction of 22 new fees for services that need cost-recovery. The fee proposals outlined in this consultation aim to achieve full cost recovery in accordance with HM Treasury’s principles on Managing Public Money and ensure that the MHRA has the resources necessary to deliver the high-quality service that patients, the general public, and industry want and expect. Source: Link |
| News from MHRA “Canada – United Kingdom Trade Continuity Agreement Protocol for Recognition of Good Manufacturing Practices” | Date of news: September 1, 2022 | Health Canada, the UK Medicines and Healthcare products Regulatory Agency (MHRA), and the Veterinary Medicines Directorate (VMD) have agreed to broaden the current method of recognising GMP inspection results so as to include inspections conducted in nations outside of the respective Parties’ jurisdictions (i.e. extra-jurisdictional inspections) for human and veterinary finished products included in the operational scope of Annex 1 of the Protocol for pharmaceuticals. Source: Link |
| MHRA published details of Fees payable to the MHRA for 2022 to 2023 | Date of news: September 5, 2022 | MHRA published details of Fees payable to the MHRA for 2022 to 2023 Source: Link |
| MHRA published “Summary of responses to consultation – new Code of Practice for the Expert Advisory Committees” | September 8, 2022 | Source: Link |
| MHRA Press release – Introduces new conflicts of interest code of practice for independent advisors | September 8, 2022 | The Medicines and Healthcare products Regulatory Agency (MHRA) is implementing a new, unified code of practise for all of its scientific advisory committees in order to ensure that the experts providing advice are independent and impartial, and that the processes in place to manage conflicts of interest are robust, consistent, and transparent to all. The new code of practise is the result of a six-week public consultation, which was launched in response to a key recommendation of the Independent Medicines and Medical Devices Safety Review for the MHRA to review how it identifies and manages potential conflicts of interest from members of expert advisory committees. The Commission on Human Medicines (CHM) and its expert advisory committees are among them. Source: Link |
| MHRA published “The main decision-making, executive and managerial bodies at the Medicines and Healthcare products Regulatory Agency (MHRA)” on its website. | September 22, 2022 | Source: Link |
| MHRA has updated Good clinical practice for clinical trials | September 27, 2022 | Source: Link |
| The MHRA has appointed the first new UK Approved Body to certify medical devices since Brexit. | September 29, 2022 | In order to guarantee that only safe and effective medical devices are distributed to UK consumers, the Medicines and Healthcare Products Regulatory Agency (MHRA) has certified that DEKRA Certification UK Ltd. has now joined the three other UK Approved Bodies. Any possible organisation must now go through the new designation procedure in order to be permitted to certify medical devices in the UK, and DEKRA has become the first organisation to do it. They are now recognised as an organisation authorised by the UK to conduct evaluations of general medical equipment (known as Part II designation). Source: Link |
| News from MHRA – The European Commission Decision Reliance Procedure (ECDRP) is still in effect till December 31, 2023. | September 30, 2022 | To ensure that British citizens continue to have prompt access to medications while MHRA develops recommendations for a new international reliance framework, the European Commission Decision Reliance Procedure has been extended by 12 months to apply across Great Britain until 31 December 2023. Source: Link |
| Medical devices: guidance for manufacturers on vigilance” | October 6, 2022 | MHRA updated its guidance with respect to the information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA. Source: Link |
| To enhance the safety of medicines and medical devices, the MHRA is evaluating its approach to engaging with healthcare professionals | Date of news: October 13, 2022 | According to the MHRA, you can engage in this consultation anonymously, but if you enter your email address, we will add you to our mailing list to provide you with future opportunity to learn about or participate in our work. Source: Link |
| Healthcare workers and their professional organisations have a unique opportunity to offer their perspectives and impact the MHRA’s safety communication and reporting systems. | October 13, 2022 | Source: Link |
| MHRA has revamped Software and AI as a Medical Device Change Programme | October 17, 2022 | Software (and AI in particular) has a wide range of uses in both health and social care, and it is becoming more and more prevalent in health systems. Many of these applications will fall within the purview of medical devices regulation. In order to ensure that patients, the general public, and healthcare professionals have access to the most advanced medical technology, it is becoming more and more crucial that medical device regulation be effective. This work plan will bring about radical change to create a regulatory framework that offers a high level of patient and public protection while also ensuring that the UK is the hub of responsible innovation for medical device software. Source: Link |
| MHRA has updated guideline on Guidance on pharmacovigilance procedures | Date of news: October 28, 2022 | The Pharmacovigilance Procedures guideline has been amended to incorporate more information on MHRA submission requirements, particularly for signals, Risk Management Plans (RMPs), and Post Authorisation Safety Studies (PASS). The section on Periodic Safety Update Reports (PSURs) has been amended with additional requirements for PSUR filing for Northern Ireland-approved items. Additional sections on MHRA Safety Reviews and Safety Communications have been added. Source: Link |
| MHRA updated guideline “Clinical trials for medicines: manage your authorisation, report safety issues” | November 8, 2022 | Source: Link |
| MHRA Return to International GMP Inspections | November 8, 2022 | The MHRA Inspectorate made a blog post in March 2020 in which MHRA declared that they will only perform on-site inspections related to the UK Government’s COVID-19 response or any other potential major public health risk until further notice. MHRA provided an update in July 2020 outlining our plans to resume a full programme of UK on-site inspections in October 2020. MHRA was unable to plan for a return to international inspections at the moment, but we promised to give more information as the situation progressed. Source: Link |
| Notice from MHRA on “Access Consortium Good Manufacturing Practice (GMP) Statement” | November 15, 2022 | Access Consortium Statement on Good Manufacturing Practice (GMP) Inspections Reliance and Recognition. Source: Link |
| MHRA Process for approving Manufacturing Authorisations or API Registrations in relation to unlicensed Cannabis-Based Products for Medicinal Use | November 16, 2022 | The MHRA has received inquiries from a number of businesses about cannabis-based medicines. This blog offers details on the authorizations needed to manufacture in this area of the pharmaceutical business, according to MHRA Manufacturing Licence Application. Please refer to the following guideline, which was revised in March 2020, for an overview of unlicensed cannabis-based products for medical use (unlicensed CBPMs). Source: Link |
| Medicines: Marketing Authorisation Holders’ submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing | November 17, 2022 | Source: Link |
| MHRA Added ‘Register of Electronic Export Certificates Issued by the MHRA (Human) | Date of news: December 08, 2022 | These documents provide information about all the electronic export certificates issued by the Department of Health and Social Care and the Medicines and Healthcare products Regulatory Agency (MHRA). Source: Link |