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Focus on Regulation

HMA-EMA’s work programme on availability of authorised medicines for human and veterinary use includes measures for Brexit

On 23 August 2018, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), the network of the National Competent Authorities in the European Economic Area (EEA), published the work programme of their joint task force regarding the availability of authorised medicines for human and veterinary use.

The HMA-EMA task force was created to develop and coordinate actions on the availability of human and veterinary medicinal products authorised in the EU. It establishes links with existing working groups and ensures that any activities related to the availability issues in their field are reflected in their respective work programmes.

The present work programme includes a number of actions and deadlines concerning how the HMA-EMA task force plans to address the problem of shortages of medicinal products in the EU. This includes potential shortages that could occur as a result of the UK’s withdrawal from the EU. These actions were agreed in February 2017 but were only published in the course of August 2018.

Lack of availability of medicinal products in the EU either because the products are not marketed or due to supply disruptions has been identified by the EMA and HMA as an area of a great concern. According to the work programme, shortages of medicinal products can have a significant impact not only on the supply chain but also ultimately on healthcare systems and on end-users.

The HMA-EMA task force has set itself a deadline for the fourth quarter of 2019 to encourage accelerated procedures by mutual recognition to extend marketing authorisations to countries where companies would not normally seek marketing authorisation. By that time, the task force also intends to facilitate and promote the use of multilingual packages to enable the transfer of medicinal products with the appropriate translation of the package leaflet to EU Member States that are experiencing shortages, in particular smaller markets. The task force also plans to review the existing procedure for withdrawal of medicinal products in the EU and explore the need for a transition period to allow better planning for any disruptions.

One action of the work programme has already been completed. The HMA-EMA task force has already facilitated the approval of generics and biosimilars through the implementation of joint evaluation (work sharing) and shortened timetables for renewals of marketing authorisations and variation applications.

Other key actions for the task force include development of a concept of reportable shortages by agreeing an EU-wide definition of “shortage” of medicinal products, development of guidance for companies on reporting of shortages, and steps to encourage them to develop best practices to prevent shortages.

Concerns have been expressed regarding the supply of medicinal products in the EU after the UK leaves the EU. As part of the work programme, the HMA-EMA task force has prepared actions to avoid potential risks of shortages resulting from Brexit. The task force intends to provide practical guidance concerning the implementation of required regulatory changes following Brexit, including change of the “reference Member States” for mutual recognition and decentralised authorised products. The task force will also monitor the implementation of these regulatory changes and take steps to minimise disruption of the supply of medicinal products and avoid shortages as a result of Brexit. Planned steps include a review of existing guidance documents for competent authorities regarding how best to manage and minimise the impact of shortages, including the shortages that may arise as a result of Brexit.


FDA publishes internal policy on prioritizing surveillance inspections for drug manufacturing sites

Earlier today, FDA Commissioner Scott Gottlieb, M.D., made publicly available for the first time FDA’s internal policy (MAPP 5014.1) for how drug manufacturing facilities are prioritized and scheduled for surveillance inspections.  According to the press release, in 2017, approximately 5,063 drug establishments were subject to routine surveillance inspection; out of these approximately 5,063 eligible drug establishments, FDA conducted 1,453 drug surveillance inspections.  Accordingly, this site selection policy (and the accompanying Site Selection Model (SSM)) is intended to clarify how FDA prioritizes inspections of sites that pose the greatest potential risks to patients.  While certain elements of this policy could be gleaned from prior public statements or presentations from FDA regarding the agency’s risk-based inspectional strategies and resource allocation, the announcement is significant in that it memorializes in a formal policy document FDA’s approach for prioritizing and scheduling surveillance inspections.

Key takeaways from this policy document include:

  • FDA’s Office of Surveillance is responsible for maintaining and applying the SSM, and generating a Site Surveillance Inspection List (SSIL). FDA’s Office of Regulatory Affairs is responsible for planning and conducting inspections based on the SSIL.
  • The SSM will be applied equally to domestic and foreign establishments. FDA’s goal is “to achieve parity in inspection frequency, meaning equal frequency for sites with equivalent risk, regardless of geography (foreign or domestic).”
  • To further FDA’s Mutual Recognition Agreement with the EU, the SSM will consider whether a particular establishment has been inspected by a foreign regulatory authority determined to be capable by FDA. (We most recently discussed FDA’s recognition of inspectional data from EU regulatory authorities here).
  • Manufacturing sites on OAI status and manufacturing sites currently on Import Alert are not included in FDA’s surveillance inspection planning; these sites are subject to inspection according to FDA’s enforcement policies.
  • Drug quality matters. A key risk component in the SSM is hazard signals, including Field Alert Reports, Biological Product Deviation Reports, MedWatch reports, and recalls.  Indeed, based on our recent experience, hazard signals may be the key risk component for moving up FDA’s SSIL.
  • Newly registered sites should expect to be inspected within 30 days after registering with FDA.

In addition to the implicit exclusions from the SSM noted above (i.e., sites on OAI status), certain establishments are expressly excluded from the SSM, including registered outsourcing facilities, medical gas sites, inactive ingredient manufacturers, and manufacturers of drugs intended for use only in clinical trials.

U.S. Senate passes bill requiring prescription drug ads to include prices (updated)

Update (9/18/2018): Last week, as the U.S. House of Representatives was reconciling its spending bill for the Health and Human Services Department (HHS) with the amendment package passed by the U.S. Senate that is discussed below, House Republicans declined to adopt S.Amdt. 3964, which would have provided HHS with $1 million to issue rules requiring pharmaceutical companies to list prices of their prescription drugs in direct-to-consumer (DTC) advertisements.  In response, several Senators issued public statements critical of the House’s failure to act, which suggests that the proposal may survive to appear in future legislation.

August 28, 2018:  On Thursday, the U.S. Senate passed (85-7) the fiscal year 2019 minibus appropriations bill (H.R.6157) that would fund the Departments of Labor, Health and Human Services (HHS), and Education, attaching to it a large amendment package.  The bill includes S.Amdt. 3964, an amendment introduced by Sens. Richard Durbin (D-IL) and Chuck Grassley (R-IA) that provides HHS with $1 million “to issue a regulation requiring that direct-to-consumer prescription drug and biological product advertisements include an appropriate disclosure of pricing information with respect to such products.”  The U.S. House of Representatives has yet to take up their version of the HHS funding bill for FY-2019, or to consider this amendment.

Vague Amendment raises Free Speech concerns, other questions

There remains significant ambiguity over whether HHS has the legal authority to enact such a rule and how any such potential regulation would be enforced.  Coalition for Healthcare Communication Executive Director John F. Kamp told the New York Times in May that a drug-price disclosure requirement, “as a form of compelled speech, could violate the First Amendment.”  The measure says HHS would enforce “appropriate disclosure of pricing,” but it is unclear what pricing information should be communicated to the consumer: the Wholesale Acquisition Cost (WAC) or a different metric.  The price that a consumer ultimately pays may not be reflective of the price at which the manufacturer makes the drug available to providers or insurers (due to various negotiated price concessions such as rebates, as well as due to the fact that benefit plan requirements that may govern patient out-of-pocket costs).  Any proposed regulation therefore would need to specify whether drug makers could include caveats regarding such differentiating factors.

Amendment sponsors attack “Big Pharma” for opposition to measure

Sen. Durbin attacked “Big Pharma” in a statement, saying they were the only groups opposed to the proposal.  Similarly, in a floor speech promoting the amendment, Sen. Grassley assailed pharmaceutical companies for lobbying against drug price transparency measures such as this.

Grassley called the measure “Midwestern common sense” and compared it to price disclosure requirements for cars or gas stations.  Grassley concluded, “We ought to be able to get some of this common sense stuff done,” confidently adding, “We’re going to get this done one way or this other.  If we don’t get it done on this bill, we’re going to get it done, because it’s the right thing to do.”

More drug pricing transparency reforms to come

Earlier last week, the Centers for Medicare and Medicaid Services (CMS) sent to the Office of Management and Budget (OMB) for review a proposed rulemaking titled, “Regulation to Require Drug Pricing Transparency,” the text of which has not been made public; it is unclear what precisely the measure would require.  Earlier this month, CMS also announced plans to begin using “step therapy” to reduce spending on Part B drugs in Medicare Advantage plans.  In February, we outlined the budget proposals of HHS and OMB, predicting more changes to come in this space.  We will continue to monitor these changes and keep you apprised as the funding bills move through Congress.

UK Government publishes first no-deal Brexit notices for food

The Government has released its first batch of technical notices which aim to prepare UK citizens and businesses for an exit from the EU without a Withdrawal Agreement on 29 March 2019. Of most relevance to food businesses are the notices on developing genetically modified organisms (“GMOs“) and producing and processing organic foods.

Under the European Union (Withdrawal) Act 2018, existing UK laws implementing European Regulations and Directives will continue to apply after the UK leaves the EU. Existing legislation will be amended so it functions effectively in the new UK-only context, for example, by replacing references to the UK as a Member State.

With regard to GMOs, this means there will be few significant implications in the event of a “no-deal” scenario. The release of GMOs will continue to require prior authorisation, which will only be granted if there are no safety concerns, as is currently the case under EU Directive 2001/18. These decisions will continue to be taken in the UK, as will regulatory decisions on marketing GMOs which have previously been made at EU level. Any EU decisions authorising the marketing of GMOs which are in force the day the UK leaves the EU will continue to apply until the expiry of the current EU consent period.

The main difference to the current regime is that the UK will be treated as a third country by the EU for trade purposes. Therefore, UK businesses will only be able to export GMO products to the EU if the GMO in question has EU marketing approval. Similarly, EU GMO exports to the UK will be dependent on the products having marketing approval in the UK. Over time, this may result in increased barriers to trade between the UK and the EU. However, overall, the impact on food businesses in the UK is likely to be low given that the only GM crop seed currently approved for commercial cultivation in the EU (MON 810 Maize) is not currently marketed or grown in the UK.

The Government anticipates more upheaval in the organic food sector. It confirms that the UK will continue to maintain high standards in food production and labelling and that UK organic control bodies will still be responsible for certifying UK organic operators. It also plans to continue accepting imports of EU organic products as well as those from countries with equivalent standards such as the USA, Canada, Japan and South Korea (although, this remains at the UK’s discretion). Nonetheless, there will be a number of substantial changes in the event of a no-deal Brexit because the UK will be treated as a third country. Notably:

  • Food labelling will need to change as UK organic operators will no longer be able to use the EU organic logo. There will be a grace period to during which existing stock can be sold through, but the UK will need to develop its own logo for use on organic products.
  • A new traceability system will replace the current EU TRACES NT system to ensure the traceability of organic food and feed imported into the UK. More information on the replacement system is expected in the coming weeks.
  • Export restrictions will be placed on UK businesses, which will only be able to export to the EU if they are certified by an organic control body recognised and approved by the EU. Problematically, UK control bodies cannot apply to the EU for recognition until the UK becomes a third country and approval can take up to nine months. The Government intends to negotiate an equivalency arrangement with the EU which will allow the free movement of organic goods between the EU and the UK in the meantime. However, if it fails to do so, this may leave the UK unable to export organic products to the EU for nearly one year post-Brexit.

Overall, the notices stress the Government’s confidence in its ability to negotiate a successful deal with the EU and maintain that these are merely contingency plans to enable UK businesses to prepare for the worst-case scenario. However, whilst providing some initial guidance, the notices suggest that there continues to be a significant degree of uncertainty regarding the UK’s position in the event of a no-deal Brexit. In particular, there does not yet seem to be a viable plan to ensure continuing trade of organic products between the UK and the EU27 on Day 1.

A further 50 or so notices are expected to be published before the end of September. As 29 March 2019 looms closer, businesses should continue to monitor these carefully and consider how they will respond to a “no-deal” outcome to ensure continuity in their operations.

The Trump Administration Issues Its R&D Budget Priorities for FY 2020

On July 31, the Director of the Office of Management and Budget, Mick Mulvaney, and the Deputy Assistant to the President, Office of Science and Technology Policy, Michael Kratsios, jointly issued a memorandum on “FY 2020 Administration Research and Development Budget Priorities.” This is an annual document, providing overall policy guidance to the federal agencies as they prepare their budget submissions for the next fiscal year. The guidance does not include any specific funding targets, or other specific direction. But the guidance does give an indication of Administration thinking, and that thinking is showing signs of better appreciating the role of federal research and development spending in building a more robust economy than reflected in last year’s guidance.

The aspect of the Administration’s approach to concerns that U.S. leadership in technology was slipping, endangering U.S. military superiority, that has grabbed the headlines has been the effort to rein China in – most notably through revisions to the law controlling foreign investments in the United States (CFIUS). These revisions are embodied in legislation entitled the Foreign Investment Risk Review Modernization Act (FIRRMA), which was incorporated into the National Defense Authorization Act for Fiscal Year 2019 (NDAA for FY 2019). As of this writing, the NDAA for FY 2019 has passed both chambers, and is awaiting presidential signature. Limiting Chinese investments in U.S. “emerging and foundational technology” companies, as FIRRMA will do, might limit the flow of U.S. developed technology breakthroughs to China, but it will do nothing to help the United States to make those breakthroughs in the first place. Indeed, it might even slow U.S. technological progress if the flow of Chinese capital to U.S. start-ups is reduced by implementation of FIRRMA.

More quietly, the FY 2020 guidance seems to reflect a different, more positive approach to the apparent slippage of U.S. technological superiority. The FY 2020 guidance declares that

Federal R&D dollars focused primarily on basic and early-stage applied research, paired with targeted deregulation, and investment in science, technology, engineering, and mathematics (STEM) education and workforce development, will strengthen the Nation’s innovation base and position the United States for unparalled job growth, continued prosperity, and national security.

The reference in the FY 2019 guidance to budget neutrality is nowhere to be seen in the FY 2020 guidance. Although both documents state that federal spending should focus on basic and early-stage applied research, the FY 2020 guidance notes the importance of programs that improve the transition of federally funded technologies from discovery to practical use. In addition, the FY 2020 guidance is sprinkled with far more references to specific technology areas, reflecting an enthusiasm that seems lacking in the FY 2019 guidance. There are references to artificial intelligence, autonomous systems, hypersonics, advanced microelectronics (including exploring novel pathways to advance computing in a post-Moore’s Law era), computing (and in particular quantum information science), and cyber capabilities (including adaptive and automated defensive measures). There is also a discussion of the importance of creating the conditions for the development of an industrial base for commercial activities in space.

Enthusiasm, and expressions of recognition of the importance of research and development, including recognition of the critical role that federal funding of basic research plays in the building of a foundation for technological leadership, is all well and good, but providing the resources to back up the words of the guidance is what really counts. If Congress adopts the Senate Appropriations Committee’s two billion dollar plus bump-up in R&D funding, compared to the House-passed bill and compared the President’s budget, that will go a long way in answering the question whether the U.S. has the will to do what is necessary to maintain its technological edge.

Please contact the authors of this post if you have any questions.

MDR and IVDR: the European Commission published some guidance documents

In the last couple of days, the European Commission published five new documents intended to provide guidance to manufacturers concerning the implementation of the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).

The documents which are available on the European Commission website include the following practical guides:

  • Factsheet for manufacturers of medical devices
  • The factsheet is intended to provide a general overview of the consequences of the MDR on medical devices manufacturers.
  • Implementation model: medical devices
  • The document is described as a step by step guide for the implementation of the MDR.
  • Exhaustive list: requirements for medical devices manufacturers
  • The document which was prepared by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) on 23 February 2018 includes what is presented as an exhaustive list of requirements applicable to medical devices manufacturers.
  • Factsheet for manufacturers of in-vitro diagnostic medical devices
  • The factsheet is intended to provide a general overview of the consequences of the IVDR on medical devices manufacturers.

For manufacturers which have not yet started to work on their preparation for the new Regulations, the above documents could be really useful as a starting point. For manufacturers which have already started to prepare for the new Regulations, the MHRA list of requirements applicable to manufacturers could constitute a useful checklist to determine if all appropriate requirements have already been considered by the company.

Our team remains available to address any question in relation to these new guides.

New EU draft guidelines on clinical trials with ATMPs open for consultation

The European Commission, together with the EMA and the expert group of the competent authorities of the EU Member States, has developed draft guidelines (the “Guidelines”) governing good clinical practice specific to advanced therapy medicinal products (“ATMPs”).

The purpose of the Guidelines is to adapt existing good clinical practice rules (“GCPs”) to ATMPs. This step is required by Article 4 of Regulation 1394/2007 on ATMP, which provides that the European Commission to draw up guidelines on GCPs specific to this category of medicinal products.

The document relates solely to ATMP and will apply in addition to the GCP Guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (“ICH”). The Guidelines also provide that investigational ATMPs must comply with the new guidelines on good manufacturing practice (GMP) specific to ATMPs.

The Guidelines discuss the areas in which specific rules would apply when a clinical trial is conducted in relation to an investigational ATMP.

By way of example:

  • The clinical trial design should take account of the specific characteristics of ATMPs and the patient populations likely to consume these. Because of the novelty and scientific uncertainties relating to ATMPs the Guidelines provide, in particular, that there may be a need for subjects to be on long-term follow-up after treatment;
  • Aspects of dosing and repeatability of treatment should be considered based on the specific characteristics of the product. Where the ATMP is expected to have long-term effects, dose escalation and repeated dosing should be considered with a view to control toxicity risks to the subject;
  • The Guidelines describe specific requirements for ATMPs containing human cells or tissues used as starting materials. In these cases, the trial application dossier should contain confirmation that the donation, procurement and testing of cells and tissues are in compliance with EU legislation, and that there is a bidirectional traceability system in place from the point of donation to administration of the medicinal product in the clinical trial;
  • The Guidelines underline that the quality of the investigational ATMPs may be highly dependent on their storage, transport and handling conditions. Sponsor should, therefore, provide investigators with detailed instructions concerning handling and storage of the investigational ATMPs;
  • The administration procedure should be clearly explained by the sponsor. The level of documentation should take into account the complexity and the novelty of the procedure;
  • The Guidelines acknowledge that in the case of ATMPs the retention of samples of the investigational medicinal product may be challenging due to scarcity of the starting materials. The general GCP rules requiring the sponsor to maintain sufficient quantities of the investigational product used in a trial to reconfirm specifications would not, therefore apply in the case of autologous ATMPs and certain allogeneic ATMPs (matched donor scenario).

The draft Guidelines can be found here and stakeholders are invited by the European Commission to comment on this consultation by 31 October 2018. The comments received will be taken into account by the European Commission in the finalisation of the Guidelines.

FDA launches Biosimilars Action Plan to spur biologics competition, finalizes labeling guidance

On July 18, FDA Commissioner Scott Gottlieb, M.D., announced the release of FDA’s Biosimilars Action Plan (BAP), saying it would help enable a path to competition for biologics from biosimilars, while preserving incentives for innovators to invest in further research.  On July 19, FDA also published the guidance “Labeling for Biosimilar Products,” finalizing an April 2016 draft guidance that Dr. Gottlieb said aims to help biosimilar manufacturers prepare labeling submissions in a manner that would achieve FDA approval.  The BAP specifically summarizes 11 steps FDA will be taking to foster the biosimilars market, including:

  • Establishing an Office of Therapeutic Biologics and Biosimilars (OTBB);
  • Exploring the option of data sharing agreements with foreign regulators, such that U.S. drug makers could evaluate biosimilars by using European or Asian drugs as comparator products;
  • Developing an index of biosimilars’ critical quality attributes relative to their reference products;
  • Implementing new FDA review tools, such as standardized review templates, that are tailored to applications for biosimilar and interchangeable products; and
  • Adding more data about approved biologics to the Purple Book.

In a July 16 statement on HHS’s Blueprint to lower drug prices, the Federal Trade Commission (FTC) had urged FDA to finalize a January 2017 draft guidance that would facilitate approval of intgerchangeable biosimilar products, which the FTC described as more likely to permit automatic substitution; Dr. Gottlieb also prioritized action on this interchangeability guidance in the BAP.

FDA announces public hearing on BAP

The FDA announced July 25 that it will hold a public hearing on September 4 to gather input on the BAP, as well as ways FDA can facilitate the development of biosimilars and ensure they enter the market in a timely fashion.  At the hearing at FDA’s White Oak HQ, the agency will solicit input from stakeholders on nine questions addressing scientific and legal challenges to bringing biosimilars to market and measures to reduce barriers to competition once they are on the market.  The registration deadline for persons seeking to attend or present at the hearing is August 14.

In its meeting notice, FDA requested comment on the potential application of “umbrella exclusivity” to biological products pursuant to section 351(k)(7) of the Public Health Service (PHS) Act.  Noting that umbrella exclusivity has long been used in the Hatch-Waxman context for small molecule drugs,

FDA points out that this approach aims to promote biological product innovation by shielding certain biologics from biosimilar competition.  Innovators should consider remarks to FDA emphasizing the importance of protecting improvements to their original products without fear that doing so within the 12-year statutory exclusivity period would expose the biologic to biosimilar competition before the sunset of the exclusivity period.  The deadline for submitting written comments is September 21.

Dr. Gottlieb decries “anemic” biosimilars competition

In his July 18 speech at the Brookings Institution, Dr. Gottlieb emphasized the “anemic” competition in the biosimilars industry, blaming a “rigged system” whereby “consolidation across the supply chain has made it more attractive for manufacturers, Pharmacy Benefit Managers, Group Purchasing Organizations and distributors to split monopoly profits through lucrative volume-based rebates on reference biologics…rather than embrace biosimilar competition and lower prices.”  Dr. Gottlieb also blamed litigation for delaying market access to biosimilars.

Dr. Gottlieb said the FDA would “soon” release the details of its analysis that found timely marketing of biosimilars in the U.S. could have saved consumers more than $4.5 billion in 2017.  Only three of 11 FDA-approved biosimilars have made it to market, and FDA has approved two biosimilars this year.  The agency is making clear its prioritization of promoting the manufacture and approval of additional biosimilars.

Brexit, medical devices and transfer of notified bodies. What will be the procedure?

In the recently published White Paper governing the future relationship between the United Kingdom and the European Union, the UK proposes a “common rulebook” between the parties in relation to goods. The White Paper discusses what is foreseen as the future relationship between the parties in some detail. Continue Reading

UK Government Publishes Guidance for Life Sciences Companies on Brexit Transition

The UK Government has published guidance for life sciences companies on the Brexit implementation period, which is intended to take effect from 30 March 2019 to the end of 2020. If the draft Withdrawal Agreement is finalised by the UK and EU, during the implementation period the UK will no longer be an EU Member State but the UK and EU will continue to access each other’s market on broadly the same terms as at present.

While the European Medicines Agency (EMA) has already published a number of guidance documents for companies, this is the first formal UK guidance for the life sciences sector. It has been produced by the UK Department of Health and Social Care (DHSC) together with the Medicines and Healthcare products Regulatory Agency (MHRA) and the Veterinary Medicines Directorate (VMD).

While the new guidance confirms the anticipated position rather than containing significant new information, it provides helpful reassurance that the UK authorities intend to take a pragmatic approach to issues such as authorising clinical trials and issuing UK marketing authorisations based on existing EU authorisations after the implementation period.

The published guidance includes:

  • Guidance on what the implementation period means for the life science sector (link);
  • Technical information on the implementation period (link); and
  • An update on the new EU Clinical Trial Regulation during the implementation period (link).

What are the key points in the new guidance?

The guidance confirms that life sciences companies will continue to be able to operate as currently. In particular, during the implementation period:

  • EU marketing authorisation holders and qualified persons (QP) can continue to be located in the UK;
  • The EU will continue to recognise UK marketing authorisations, manufacturing and distribution licences, GMP inspections, batch release testing and QP certification (and visa versa);
  • Pharmacovigilance activities of EU marketing authorisation holders can continue to be based in the UK, including the location of the qualified person for pharmacovigilance (QPPV) and of the pharmacovigilance master file (PSMF);
  • Labelling requirements will remain unchanged and multi-country packs for medicinal products will continue to be valid in both the UK and EU;
  • The EU will continue to recognise medical devices that have been CE marked by a manufacturer in the UK and devices that have been assessed by a UK notified body (and vice versa); and
  • The UK will continue to be treated as an EU Member State for the purposes of international agreements, including Mutual Recognition Agreements.

However, although UK companies will continue to be able to use both the EU centralised and decentralised procedures for marketing authorisations, the MHRA will no longer be able to act as the lead authority (Reference Member State) for the assessment of these applications. In particular, the guidance flags that companies should consider the expected conclusion date for applications submitted through the decentralised procedure, as the EU does not currently permit transfers of the appointed Reference Member State before the conclusion of the application process.

The status of new EU Regulations

The new EU Clinical Trials Regulation is expected to come into effect during the implementation period, and will apply in the UK during this period as part of EU law. The new Regulation streamlines the application process for multi-site clinical trials in the EU and simplifies reporting procedures. If the new Regulation does not come into effect during the implementation period, the UK Government has confirmed that it still intends to implement the Regulation into UK law as far as possible. The Guidance recognises that the UK’s participation in EU clinical trial systems after the implementation period will be subject to negotiation with the EU. If the UK is unable to negotiate continued participation in this system, the guidance reassures companies that the UK will put in place a streamlined and efficient approval process for UK clinical trials.

The new EU Medical Device Regulation (MDR) will apply fully from May 2020 (i.e. during the implementation period) and so will apply directly in the UK. The new EU In-vitro Diagnostic Medical Device Regulation (IVDR) only applies fully from May 2022, i.e. after the implementation period. The guidance reminds companies that IVDs which are in conformity with the new IVDR have been permitted on the market since May 2017 under the new regime, suggesting that this will continue to be the case following the implementation period.