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Supply Chain Risk

Regulatory Compliance Trends – Contract Pharma

The disruptive impact of Covid-19 on medicine and medical device supply has placed many regulatory and compliance teams under pressure. The life sciences industry was already undergoing significant regulatory change prior to the pandemic, and must now rapidly address new challenges and priorities.

As the situation continues to evolve, businesses must assess how they can use their limited resources efficiently. Re-appraising the balance between in-house capabilities and strategic outsourcing relationships could present invaluable solutions and also opportunities. More specifically, employing strategic outsourced solution providers as needed can provide essential support for strategically managing the current temporary volatility, but also for meeting long-term regulatory needs. The benefits are many; being ready for quality and regulatory compliance speeds time to market, reduces the risk of products being taken off the market, and may even help to increase market share where demand is growing.

In the pharmaceutical sector specifically, the global regulatory affairs outsourcing market is expected to be worth $14.3 billion by 2026, a CAGR of 12%.1 Meanwhile, the whole medical device outsourcing market is expected to be worth over €230 billion by 2027.2 There is clearly a growing trend for quality, compliance and regulatory outsourcing, and it is likely to be accelerated by the healthcare crisis.

However, outsourcing is not simply for the purpose of augmenting resource capacity, though this is a significant and immediate concern. It should also enable access to skilled, capable and experienced resources, at the time and location where they are most needed. When issues need resolving immediately, there is no luxury of time to train in-house teams, nor is it cost-effective to invest in building skills that are only needed periodically. The increased use of outsourced services suggests that many businesses are recognizing its potential for increasing businesses agility, and the possibilities for tapping into sources of useful expertise.

To ensure that these services are used strategically, businesses must periodically re-assess how internal resources and capital are being deployed, evaluating which functions can be performed internally and which are best outsourced to specialist service providers. Not only is this beneficial for future planning, but will also help to avoid rushed decision-making when issues arise. For life sciences businesses, there are a number of key areas which will need to be taken into consideration when planning ahead and allocating resources.

Firstly, regulators, buyers and suppliers must focus on facilitating the availability of existing therapies and equipment needed to manage the pandemic. In the EU, member states have been asked to ensure that companies increase production where needed and work at full capacity.3 This cannot be achieved without a degree of relaxation of regulatory measures.

Regulators have introduced a number of temporary emergency accommodations and authorized derogations from some assessment procedures, not only to maintain supply, but also to accelerate the development of new therapies. The FDA, for instance, has issued many Emergency Use Authorizations (EUAs) during the course of the pandemic, including molecular tests to detect active cases of the virus, and antibody and antigen tests to determine those who have had the virus. However, businesses must ensure their regulatory submissions remain robust despite the time constraints.

They must also be aware that some temporary measures may remain in place after the pandemic, such as the U.S. FDA formalizing an enhanced supply chain compliance and capability evaluation, or the growth of remote inspections in the U.S. and Europe. Remote inspections is just one area where regulators may see efficiency benefits that can be carried into the long-term. This means regulatory departments will need to keep up with evolving requirements, such as new communications protocols and documentation requests; adapting to these changes quickly and efficiently will be advantageous for life science businesses.

The pandemic is causing disruption in the medical supply chain. One area of concern at the beginning of the pandemic was the supply of active pharmaceutical ingredients, with the FDA identifying a selection of drugs dependent on API supplies from China. The regulator also identified 63 manufacturers which represent 72 facilities in China that produce essential medical devices; essential devices are those that may be prone to potential shortage if there is a supply disruption.4

Indeed, many U.S., UK, and EU production and supply capabilities are in China, India and South East Asia; high demand for some products, coupled with political issues that may impact supply, may put some supply chains at risk. Moving forwards, many manufacturers will be looking to alternative or additional geographies to ensure products remain available, and safeguard their supply chain.
However, sourcing products elsewhere or shifting manufacturing operations raises new regulatory complexities. RA/QA professionals will need to review compliance requirements for design and validation activities to take place in other locations. Under the EU Medical Device Regulation (EU MDR), complex supply chains will be under vigorous review, as each ‘Economic Operator’ with a commercial interest in a device must comply with a set of strict requirements, including importers and distributors.

The EU Medical Device Regulation (EU MDR) was set to come into force on May 26, 2020. To allow businesses to cope with the immediate impact of the pandemic, the new date of May 26, 2021 was approved by the European Parliament in April.5 Even before the pandemic, many businesses were struggling to meet the requirements of this transformative new regulation. The additional time presents an opportunity for manufacturers to review their Clinical Evaluations and Technical File documentation, assess Post Market Surveillance documentation, and properly evaluate Economic Operator relationships and agreements. This will place businesses in good stead to cope with increased regulatory demands resulting from COVID-19, and manage emerging post-pandemic requirements.

Pharmaceutical, biopharmaceutical and biologics companies must also be informed of the implications of the EU MDR, as well as the EU In Vitro Diagnostic Regulation which comes into force on May 26, 2022. The EU MDR impacts combination products currently regulated as medicinal products; the ancillary medical device parts of these products will now be subject to the same level of scrutiny as stand-alone medical devices.

Meanwhile, the EU IVDR introduces a definition for companion diagnostics for the first time. This term refers to IVD devices used to identify patients most likely to benefit from a corresponding medicinal product and patients likely to be at increased risk of serious adverse reactions. Since many pharmaceutical companies may not have prior experience in medical device regulation, they must take advantage of the time remaining before the deadlines to understand and implement these requirements, as a matter of urgency. Third party experts with established expertise in these regulations can help to speed up the process, by identifying what needs to be done and helping to formulate a compliance plan.

As a result of the pandemic, regulators are keenly aware of areas where more can be done to strengthen the healthcare system’s response capabilities and emergency preparedness. The European Medicines Agency (EMA) is setting up the i-SPOC (industry single point of contact) system, to fast-track industry reporting on shortages of medicines.6 In the U.S., the FDA put forward four specific proposals to Congress in February, to prevent or mitigate medical product shortages. 

The first proposal concerns short expiration dates which force the disposal of drugs even when there is a shortage. If the FDA had the authority to require the longest possible expiration date that is scientifically justified, this would help to alleviate shortages. Secondly, the FDA is seeking authorization to require application holders of certain drugs to conduct periodic risk assessments. This is because many medical product manufacturers lack sophisticated plans to assess and address vulnerabilities in their manufacturing supply chain, inclusive of contract manufacturing facilities. Thirdly, the FDA would be better equipped to assess critical infrastructure, and manufacturing quality and capacity, if data sharing requirements could be strengthened.

Lastly, the organization is seeking to establish the same level of authority for medical device shortages as for drugs and biological products. This last proposal is now enshrined in the CARES act, which provides the FDA—for the first time—with authority intended to help prevent or mitigate medical device shortages “during, or in advance of, a public health emergency.”7 In sum, manufacturers must be prepared for an increase in overall scrutiny, and transparency and reporting requirements as the pandemic continues to unfold.

The emergency situation has created a number of issues that life sciences must now urgently tackle in the coming months. As the situation evolves, they will need to stay informed of the latest regulatory developments and secure their supply chains. Business agility and scalability is indispensable for navigating this continually evolving landscape.

Companies must therefore leverage managed outsourcing platforms to achieve regulatory and quality compliance in new normal conditions, and consistently meet deadlines. If there are rapid changes in circumstances, these companies will have support across a range of specialist knowledge bases, whether for a certain product type, geography or regulation. This can be deployed when it is most needed, reducing risk for the organization. Achieving this balance of in-house activity and outsourced support will position companies well to weather current and future regulatory obligations. 

Maetrics’ whitepaper on this topic, “Strategy Review: a portrait of post pandemic pharmaceutical, diagnostic and medical device regulation,” is available for download here: https://bit.ly/2QbQHNQ

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. Baker McKenzie, COVID-19 EMEA Life Sciences Survey
  4. FDA, Coronavirus (COVID-19) Supply Chain Update, 27 Feb 2020
  5. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2020.130.01.0018.01.ENG
  6. EMA, EU authorities agree new measures to support availability of medicines used in the COVID-19 pandemic, 6 Apr 2020
  7. FDA, Coronavirus (COVID-19) Supply Chain Update, 27 Feb 2020
  8. FDA, Medical Device Shortages During the COVID-19 Public Health Emergency, 20 August 2020


Stephen Cottrell is the President of Maetrics and is responsible for the client service delivery, growth, and overall performance of the company. He leads an experienced team of industry professionals who formulate and deliver consulting services dedicated to the life sciences industry. Mr. Cottrell’s experience encompasses leading a wide array of business services within the life sciences sector, including business process outsourcing, strategic sourcing, and clinical trial offerings.

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