Regulatory compliance: a re-evaluation of strategic subcontracting relationships in the “new normal”

The disruptive impact of Covid-19 on the supply of medicines and medical devices has put many teams with responsibility for regulation and compliance under pressure. Even before the pandemic, the life sciences industry was already undergoing significant regulatory changes and must now rapidly take on new challenges and priorities.

While the crisis continues, companies must aim at optimal use of their limited resources. Re-evaluating the balance between internal capacities and strategic subcontracting relationships could present solutions and invaluable opportunities. More precisely, having recourse to suppliers of strategic subcontracting solutions, according to need, can provide essential support for the strategic management of the current temporary volatility, as well as meeting regulatory needs in the long term. The advantages are numerous: being in full regulatory compliance accelerates the process of placing products on the market, reduces the risk of product  withdrawal from the market, and may even help to grow market share when demand increases.

 

1. An offer of expertise

In the pharmaceutical sector in particular, the global subcontracting market for regulatory affairs should represent $14.3 billion by 2026, that is a CAGR (compound annual growth rate) of 12 %. In parallel, the entire medical device subcontracting market should represent more than €230 billion by 2027. A growing trend towards the outsourcing of regulatory affairs, of quality and compliance, is clearly observed: a trend which may well accelerate after the health crisis. However, the aim of subcontracting is not solely to increase resources, although this is an important and immediate concern. Subcontracting also allows access to competent, experienced resources, at the time and in the area where there is most need. Confronted by urgent problems, there is no time to train internal teams, and investing in the development of skills which are only in demand periodically is not cost-effective.

The increased use of outsourced services suggests that many companies recognize the potential of subcontracting to increase their agility, and the possibilities that this offers to exploit new, useful sources of expertise.

To ensure that these services are used strategically, companies must periodically re-evaluate the way in which resources and internal capital are deployed, by assessing which roles can be carried out internally and those which would be better placed with providers of specialist services. This is not only beneficial for future planning, but also avoids hasty decision-taking when problems arise. For life science companies, there are a number of key areas that must be considered during planning and allocation of resources.

 

2. Immediate pressures

Firstly, regulators, purchasers and suppliers must try to facilitate the availability of existing therapies and of the equipment necessary to manage the pandemic. The regulatory authorities have introduced a number of temporary emergency measures and authorized exemptions for certain assessment procedures, with the aim not only of maintaining  supply, but also of accelerating the development of new therapies. The FDA, for example, has issued numerous Emergency Use Authorizations (EUA) during the pandemic, including molecular  tests to detect active cases of the virus, and antibody and antigen tests to  identify those who have already had the virus. However, companies must ensure that their regulatory submissions remain robust despite time constraints.

They must also be aware that some temporary measures may remain in place after the pandemic, such as the formalization by the American FDA of a better assessment of supply chain compliance and capacities, or the increase in remote inspections in the United States and in Europe. Remote inspections are just one of the areas in which the regulatory authorities may see advantages in terms of the efficiency that may be achieved in the long term. This means that regulatory departments will have to monitor changes in requirements, such as new  communication protocols and documentation requests; rapid, efficient adaptation to these changes will be advantageous for life science companies.

 

3. Disruption of the supply chain

The pandemic is causing disruption in the medical supply chain. One of the main concerns at the beginning of 2020 was that many production and supply capacities for the United States, the United Kingdom, and the EU were located in China, in India and in South-East Asia.

For example, in 2019, China was the largest global exporter of personal protective equipment (PPE), with a 50% share of American PPE imports and 45% of European  PPE imports. In the future, many manufacturers will turn to other geographic regions to ensure that products remain available and to protect their supply chain. However, obtaining a supply of products from somewhere else or moving manufacturing operations raises new regulatory complexities. QA/RA professionals will have to review compliance requirements so that design and validation activities can take place in other locations. In accordance with the EU regulation on medical devices, complex supply chains will be subjected to rigorous examination, as each “economic operator” with a commercial interest in a device, including importers and distributors, will have to comply with a set of strict requirements.

 

4. Deferment of the MDR target date

The EU regulation on medical devices (MDR) was intended to come into force on 26 May 2020. To allow companies to address the immediate impact of the pandemic, the new date of 26 May 2021 was approved by the European Parliament in April. Even before the pandemic, many companies were having difficulty in satisfying the requirements of this new transformative regulation. This additional period gives manufacturers the opportunity to review their clinical assessments and their technical dossier documentation, to assess post-market surveillance documentation and to correctly evaluate relationships and agreements with their economic operators. In this way companies will be well placed to address the increased regulatory requirements resulting from COVID-19 and to manage the new post-pandemic requirements.

Pharmaceutical, biopharmaceutical and biological companies must also be informed of the implications of the EU MDR, as well as those of the European regulation on in vitro diagnosis (IVDR), which will come into force on 26 May 2022. The EU IVDR has an impact on combination products currently regulated as medicines; the parts of these products which are auxiliary medical devices will from now on be subject to the same level of examination as stand-alone medical devices. At the same time, the EU IVDR  is for the first time a definition of companion diagnostics. This term designates in vitro diagnostic devices used to identify those patients most likely to benefit from a corresponding medicine and those that may suffer adverse effects. Given that many pharmaceutical companies do not have prior experience with medical device regulations, they must make the most of the time they have left before the deadlines to understand and implement these requirements, with all urgency. Third party experts with established expertise in these regulations may help to accelerate the process, by identifying what must be done and by helping to formulate a compliance plan.

 

5. Forthcoming measures

Because of the pandemic, the regulatory authorities are very conscious of the areas in which it is possible to do more to increase emergency preparedness and response capacities within the healthcare system. The European Medicines Agency (EMA) has put in place a single point of contact system for the industry (i-SPOC system), in order to accelerate notification by the industry of medicine shortages.

In the United States, the FDA presented four specific proposals to Congress in February, in order to prevent or reduce medical product shortages. The CARES law (Coronavirus Aid, Relief, and Economic Security) which followed introduced provisions aiming to rectify vulnerabilities in the supply chain. The law introduced additional requirements for reporting in response to medicine shortages, and manufacturers of essential medicines must now maintain emergency and redundancy plans in order to identify risks to the supply of medicines. With regard to medical devices, the law gives the FDA new capabilities to help to prevent or reduce medical device shortages “during or before a public health emergency”. In summary, manufacturers must prepare for an increase in general review, in transparency and in reporting requirements as the pandemic develops. Companies must systematically carry out audits of their suppliers in order to keep up to date with current and emerging requirements, as well as to pre-emptively identify problems that could arise. Experienced audit specialists are capable of identifying problems and of suggesting practical solutions, and they should also be able to give advice on how to incorporate the reporting and processes into global quality programs.

 

6. Reducing the load

The emergency situation has created a number of problems which life sciences companies must now tackle with all urgency. In the coming months, they must keep themselves informed about the latest regulatory developments and secure their supply chains. It will be essential that companies are agile and open to change to navigate this constantly changing regulatory landscape. Companies must therefore make good use of suppliers of strategic subcontracting solutions to ensure regulatory and quality compliance in the “new normal” and to comply consistently with deadlines. In the event that circumstances change rapidly, these companies will have support from  a full range of specialist knowledge databases, whether for a particular product type, a particular geographic area, or a particular regulation. This support can be deployed at the time when it is most needed, which reduces the risks for the organization. When this equilibrium between internal activity and outsourced support is achieved, companies will be well placed to deal with current and future regulatory obligations.

The complete white paper on this subject – Strategy Review: a portrait of post pandemic pharmaceutical, diagnostic and medical device regulation – can be downloaded from the following address: www.RQMPlus.com

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Steve COTTRELL –  RQM+

Steve Cottrell est responsable de la prestation de services aux clients, de la croissance et des performances globales de l’entreprise. Il dirige une équipe expérimentée de professionnels du secteur qui élaborent et fournissent des services de conseil dédiés à l’industrie des sciences de la vie. L’expérience de M. Cottrell englobe la direction d’un large éventail de services commerciaux dans le secteur des sciences de la vie, notamment l’externalisation des processus d’entreprise, l’approvisionnement stratégique et les offres d’essais cliniques.

info@rqteam.com

Glossary

MDR Medical Device Regulation

IVDR In Vitro Diagnosis Regulation

FDA Food and Drug Administration (American agency for food and medicinal products)

EUA Emergency Use Authorization

PPE Personal Protection Equipment

EMA European Medicines Agency

References

[1] Acumen Research and Consulting, The Regulatory Affairs Outsourcing Market 2018-2026, 3 Apr 2019

[2] Medium, Covid-19 impact: What is the Medical Device Outsourcing Market size?, 13 May 2020

[3] Statista, Top personal protective products exporting nations worldwide in 2019 02 June 2020

[4] Statista, Chinese share among selected U.S. imports of medical supplies and equipment in 2019, 20 July 2020

[5] European Parliament, EU imports and exports of medical equipment, October 2020

[6] https://eur-lex.europa. eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2020.130.01.0018.01.ENG

[7] EMA, EU authorities agree new measures to support availability of medicines used in the COVID-19 pandemic, 6 Apr 2020

[8] FDA, Coronavirus (COVID-19) Supply Chain Update, 27 Feb 2020

[9] White & Case, Impact of the CARES Act on the Pharmaceutical and Medical Devices Industries, March 2020 https://www.

whitecase.com/publications/alert/impactcares-act-pharmaceutical-and-medicaldevices-industries

[10] FDA, Medical Device Shortages During the COVID-19 Public Health Emergency, 20 August 2020