Regulatory challenges during a pandemic. How pharmaceutical organizations can cope up during these unprecedented times?

Abhishek Sinha, Director Global Regulatory Affairs, ADVANZ PHARMA2020 witnessed one of the most unprecedented challenges for the human race with almost all the industry sectors being impacted by the pandemic, some more severely than the others. The pharmaceutical industry was no different. Manufacturing and Supply Chain were the worst affected with lockdowns declared in almost all parts of the world, resulting in limited manufacturing capacity and restricted sources to procure active pharmaceutical ingredient (API) as well as intermediates and excipients leading to supply challenges throughout.

Increase in demand for certain essential medicines led the governments and manufacturers to re-prioritise manufacturing plans that not only affected revenue but also led to an out of stock situation for other non-essential drugs thus impacting patients who depended on them.

With China accounting for roughly 40% of global API production, the majority of APIs for generic drug manufacturing across the globe being sourced from India, which also supplies approximately 30% of the generic APIs used in the US, the pandemic took a heavy toll on the API procurement from these two countries. This led the industry to revisit their supply chain arrangements and start considering qualification of alternate sources wherever there were risks, however with the regulatory complexity and timeframe involved, it was not an easy task.

However, the biggest challenge in my view was ensuring the wellbeing of everyone working in the healthcare sector including the Pharmaceutical industry. To be able to provide patients with the medicines they need, it was important that pharmaceutical companies had agile working policies, the right infrastructure to allow remote ways of working and a greater level of empathy and sensitivity towards the welfare of their employee’s wellbeing.

This article talks about the measures that can help pharmaceutical companies to stay focussed and effectively manage business continuity at such difficult times. I have used my experiences in my current organisation, and I hope the references of what we did at ADVANZ PHARMA will be a good example so that others can benefit.

1. Safeguard your staff

Nothing is more important than safeguarding the wellbeing of your staff. At ADVANZ PHARMA, from the very beginning of the pandemic, we changed gears and started working on Business Continuity Plans. This included getting all the necessary infrastructure put in place swiftly to enable staff working remotely while having an agile and responsive working policy that was able to adapt to changing government guidelines. Although flexible working hours provide employees with a work life balance, working remotely can also very easily blur the boundaries so ADVANZ PHARMA increased its engagement with staff at many levels including holding virtual townhalls, HR-led mindfulness sessions, virtual team meetings, one on ones to check on the mental and physical well being etc.

IT and HR played a mammoth role as the organisation transitioned from office working to virtual way of working within weeks. We also let creativity flow in as we encouraged staff to think of creative ways to build in moments of fun at work either through virtual coffee sessions or conducting virtual quizzes, escape rooms and various such events.
Importantly, our leaders across each function led from the front, working hard to remain in touch and maintain connection with their teams while being empathetic and supportive.

2. Manage your priorities

At ADVANZ PHARMA, one of the earliest exercises that helped us as a business was our assessment to anticipate surges in demand for certain category of products (essential medicines). This allowed us to engage with our manufacturers early on and take necessary steps to mitigate any risks we could envisage to their supply. At the same time, we remained engaged with our customers, our partners and specially the regulatory authorities, being completely transparent about any out of stock situation that was anticipated. Awareness of various flexibilities allowed by regulators allowed us to negotiate alternate supply strategies, in many cases avoiding a stock out situation.

3. Cross-functional working

While there is nothing new in cross-functional working and like any business, this is a key success factor in the pharmaceutical industry as well as others, it can be very easy to allow silos culture to creep in and hence one should be more mindful of that. Having regular communication with your stakeholders, asking for feedback and appreciating and celebrating success cross functionally often helps foster collaboration.

4. Be aware of the regulatory flexibilities and expedited pathways allowed by Health authorities and where possible use them

Regulatory authorities have been extremely pragmatic in this situation with many flexibilities being adopted to enhance patient access to medicines. Some examples are presented below

a. MHRA, UK, suspended the 30-day limit for replies to questions on Type IB variations, extended the permitted implementation period for label/leaflet changes following a variation from 6 months to 9 months, expedited batch specific variation assessment for supply critical applications and allowed over-labelling of foreign language packs for UK market on a case-by-case basis

b. European Medicines Agency (EMA) published the Guidelines on the optimal and rational supply of medicines to avoid shortages during the COVID-19 outbreak. It also introduced the concept of Exceptional Change management procedures which can be used to reduce the risk of shortages or disruption of supply resulting from manufacturing and/or supply problems. Specifically, an exceptional change management process (ECMP) is made available to MAHs of crucial medicines for treatment of COVID-19 patients. Under the ECMP, MAHs will be able to exceptionally source starting materials, reagents, intermediates or active substances from suppliers not specifically mentioned in the marketing authorisation if that is necessary to prevent/mitigate shortages of supplies in the EU. EMA also postponed the date to implement the new Medical Device regulation to May 2021.

c. HPRA, Ireland, postponed all GXP inspections and agreed to extend the permitted implementation time from six months to nine months for labelling and/or package leaflet updates following variation approval for the duration of the COVID-19 pandemic

d. SAHPRA, South Africa postponed all GMP Inspections

e. TGA, Australia postponed its Pharma covigilance Inspection program

f. CDSCO India extended validity of GMP Certificates and Certificate of Pharmaceutical Products owing to COVID

g. Many health authorities including EMA, MHRA, FDA, CDSCO amongst others have come out with expedited regulatory pathways to approve medical devices and vaccines – for example rolling regulatory review and approval, Emergency use authorisation etc.

h. Issuance of eCPP (electronic Certificate of Pharmaceutical Products) by some health authorities allows to make procedures like legalisation redundant.

5. Explore opportunities to de-risk your supply chain

Companies should consider qualifying secondary API sources and additional drug product manufacturing sites where possible to de-risk the supply chain and the COVID situation was yet another reminder of that.

While the world is still grappling with the challenges of COVID and any cure sounds months away, the pharmaceutical industry has adjusted to the new normal and on an optimistic note, I am very sure we will all come out of it more resilient with some great learning and new ways of working that will stay with us for a long time.