Regulatory and compliance teams faced immense pressure after Covid-19 spread across the globe. The life sciences industry was trying to inculcate regulatory changes however, the pandemic expedited the need to put these into effect and to address all the new challenges at the earliest. Businesses have learned to adapt to the changing situations and must now see how to use their in-house resources efficiently while ensuring they balance their outsourcing relationships. When companies plan for strategic outsourced solutions, they prepare for the changes in regulatory compliance, reduce the risks of product recalls and meet the demands of a growing market.
What should their new outsourcing strategies keep in mind as per the current regulatory compliance trends?
- Factoring in outsourcing markets in their solutions
- Taking care of immediate pressure points
- Addressing supply chain disruptions
- Preparing for upcoming updates
1. Factoring in outsourcing markets in their solutions
According to Medium, the entire medical device market for outsourcing is expected to be worth over €230 billion by 2027. The market seems to be seeing a growth in trends that look at quality, regulatory outsourcing and compliance. The resources should include skilled and experienced professionals who must be able to tackle urgent issues immediately. This is cost effective for companies who don’t have to focus on spending time upskilling and training teams in-house especially for situations that arise periodically. It is important for companies to periodically evaluate what tasks and functions can be allocated to internal departments and what are best to outsource to specialists. Businesses are relying more and more on these outsourced services as it allows agility and more knowledgeable and experienced experts to address issues right away.
2. Taking care of immediate pressure points
According to the COVID-19 EMEA Life Sciences Survey, in the EU companies have been asked to increase production where it’s needed and to work at full capacity. Regulators, suppliers and buyers have to first use the existing equipment and assets currently available to them to manage the pandemic. Regulators have shown some temporary emergency changes for a few assessment procedures to ensure the supply of goods flows without disruptions. However, businesses still need to ensure they adhere to regulatory updates and submit the necessary regulatory requirements despite any time constraints. For Regulators, they will need to ensure they adapt to the changing requirements (i.e. documentation requests or new protocols for communication) quickly and also expect a few current temporary procedures to carry forward post the pandemic (remote inspections).
3. Addressing supply chain disruptions
When Covid-19 was on the rise, a big area of concern was the supply of pharmaceutical ingredients (especially those that had dependency on other countries such as China and India). Any disruptions led to shortages of the drug and caused massive blockages and disruptions in distribution. Some high demand products were impacted because of political problems which resulted in many manufacturers looking for alternative locations to ensure product availability. New sourcing locations must consider new regulation complexities so RA and QA professionals will need to review these requirements. The EU Medical Device Regulation (EU MDR), will strictly review each ‘Economic Operator’ and each device in complex supply chains must comply with rigid requirements, including those for importers and distributors.
4. Preparing for upcoming updates
The pandemic exposed the areas where healthcare can be strengthened and how current systems can be more responsive towards emergency situations. The European Medicines Agency (EMA) is working on the i-SPOC (industry single point of contact) system. This is to fast-track industry reporting on shortages of medicines. In America, the FDA proposed four proposals to Congress back in February, to prevent or mitigate medical product shortages. Manufacturers must be ready for cases when there’s an increase in overall scrutiny, and transparency and reporting requirements throughout the pandemic. The Life Sciences industry must stay informed about the latest regulatory changes and developments to secure their supply chains. Businesses must prepare by planning solutions in the evolving environment and should be agile and scalable. This is where outsourcing can prove to be a boon to help achieve regulatory and compliance deadlines. As the changes keep coming in, having a base of specialists to help them navigate the complexities of these changing requirements will reduce risks and balance the current support from in-house activities so they achieve all future regulatory commitments.
- Medium, Covid-19 impact: What is the Medical Device Outsourcing Market size?, 13 May 2020
- Baker McKenzie, COVID-19 EMEA Life Sciences Survey
- FDA, Coronavirus (COVID-19) Supply Chain Update, 27 Feb 2020
- EMA, EU authorities agree new measures to support availability of medicines used in the COVID-19 pandemic, 6 Apr 2020
- FDA, Medical Device Shortages During the COVID-19 Public Health Emergency, 20 August 2020