DDReg Pharma

DDReg Pharma

Importance of Collaboration between Global Regulators

Regulatory authorities across the globe play a pivotal role in safeguarding patient safety and ensure regulatory compliance. Each authority functions in its unique way to uphold standards and ultimately ensure the well-being of individuals. In the UK, the MHRA shoulders the vital responsibility of ensuring that medicines, medical devices, blood components for transfusion are safe, of good quality and effective. The MHRA is not only a regulator but also functions as an independent laboratory carrying out batch release testing, and a WHO Collaborating Centre for Biological Standards producing reference materials establishing international standards for biological products in the world.

The UK MHRA has faced many changes post Brexit with respect to regulations, and has highlighted the need for partnership between global regulators, healthcare professionals, and other key stakeholders within the industry to ensure ongoing compliance, patient safety, and access to safe, efficacious, and high quality medicines.

UK MHRA’s futuristic vision

In an interview between the US FDA Office of Global Policy and Strategy (OGPS) and Dr. June Raine DBE, CEO of UK MHRA, she mentioned their corporate plan to help achieve the UK MHRA’s futuristic vision in ensuring patient safety & access to safe medicines by way of 4 important objectives, or “pillars”.

Pillar 1: Maintain public trust & facilitate transparency with respect to all regulatory decisions.

Pillar 2: Enabling access by improvement pathways that prolong regulatory process. For example, the International Recognition Procedure (IRP).

Pillar 3: Regulatory & scientific excellence especially through strategic partnerships i.e., with Genomics England, Our Future Health, and other alliances to enhance regulations.

Pillar 4: Creating an environment in which UK MHRA employees flourish and enjoy what they do.

Enhancing Global Partnerships

One central pillar of MHRA’s strategy is the emphasis on international collaboration as seen in projects like the Access Consortium and global partnerships with regulatory bodies. MHRA is also actively participates in the International Coalition of Medicines Regulatory Authorities (ICMRA) and International Conference on Harmonization (ICH) platforms which help to shape regulatory frameworks and disseminate best practices globally.  

In the interview, Dr Raine expressed her gratitude to Project Orbis for their outstanding efforts in assisting individuals in dire need of quick access to cancer medications. Ten new cancer medications were approved between May 2021 and December 2023, and eight more approvals for the expansion of the indications of already-approved oncology treatments were granted during this time, highlighting the field’s crucial significance in urgent clinical situations.

Dr Raine said that the only way for advancement to take place was through international regulations with collaborations, UKs’. Some programs that balance promise and thorough data gathering and risk evaluation in this sector include European Medicines Agency’s Priority Medicines (PRIME) initiative and FDA’s Breakthrough Therapy designation, which offer proactive support to pharmaceutical companies. This strategy is demonstrated by ILAP as a program example thereby enhancing decision making on benefit-risk management and promoting public understanding of uncertainty.

One huge partnership is between the MHRA software and AI group and FDA colleagues at the Digital Health Center of Excellence especially now when technology is being used for public health with safety assurance. This collaboration should teach us how to use technology safely and effectively at a time when everyone wants safe utilization of technological advancements. New legislation is coming soon or AI Airlock regulatory sandbox going live among others aimed at fostering innovation without compromising safety.

ICMRA has emerged as a significant player in global cooperation initiatives and MHRA has made substantial contributions to such networks as the Public Health Emergency Clinical Trials Network and the Vaccines Vigilance Network.

FDA also is involved with African Union Smart Safety Surveillance initiative on pharmacovigilance, which is aimed at enabling Africa to have its own safety monitoring systems by getting equipped and trained. During the time of COVID-19 vaccination roll out in Africa, AU-3S played a crucial role in addressing safety concerns. It should be noted that AU-3S has received over 40,000 cases of suspected adverse reactions, thus indicating its effectiveness. Consequently, whilst considering health coverage from Africa’s public level, AU-3S has extended beyond its initial target audience of five nations.

MHRA’s Challenges and Opportunities as regulators.

While speaking acutely, Dr. Raine has identified a problem and an opportunity for the regulators to deal with not only simple but also fast-moving technologies such as artificial intelligence and personalized medicine.

As the conversation draws to a close, Dr Raine pointed out that misinformation, disinformation, misinterpretation of scientific facts are key problems that can be solved by transparency, open communication, public participation in decision making which could ultimately build trust on regulatory agencies. It is observed that globally health care regulators need to work together to foster supply chain resilience and combat counterfeit drugs while improving data governance.

In a subsequent meeting with a delegation from the FDA led by Commissioner Dr. Robert M. Califf, Dr. Raine reaffirms her commitment to fostering collaboration and identifies key areas for joint action, from combatting misinformation to enhancing clinical trial practices and leveraging real-world data for regulatory decision-making. 


Dr. June Raine DBE of the UK MHRA is recognized as a thinking leader who promotes a strategy for overseeing regulations that puts patient safety first, encourages innovation and promotes international cooperation. Her perspectives provide advice for regulators around the world as they manage the challenges of regulating healthcare products in an age of technological progress and global connectivity. In a world of global collaborations, there is a need to increase partnerships between regulators to ensure access to safe, efficacious, and high-quality medicines for the sake of patient safety.