Navigating regulatory and safety hurdles in global clinical trials
In the dynamic global drug development industry, achieving success requires more than just innovative therapies – it demands meticulous planning and steadfast adherence to regulatory and safety standards.
For executives in small- to mid-sized pharmaceutical or biotech companies, the journey from concept to market launch is often filled with complexities.
The journey necessitates orchestrating a flawless development plan, including country-specific strategies, well before enrolling the first patient.
At the core of this objective lies the indispensable role of strategic development partners.
These partners bring critical knowledge and guidance to the table, adeptly navigating the diverse landscape of global regulations and ensuring every regulatory and safety detail is thoroughly addressed from the outset.
Pillars of compliance
Staying ahead of regulatory intelligence: In global clinical trials, regulations can vary and evolve across regions to adapt to the changing environment.
From adhering to ICH GCP standards to the planned EU pharmaceutical reforms announced in 2023, meticulous attention to healthcare legislation is paramount.
Moreover, differences in submission requirements, such as varied formats for documentation and language translations, necessitate a deep understanding of the external regulatory environment.
Navigating Divergent Regulatory Requirements: Unlike the international harmonised and standardised eCTD format for product licensing submissions, the format for submitting the clinical trial application is not harmonised.
This divergence in format and content poses challenges in maintaining consistency across core documents like the protocol, chemistry, manufacturing & control information, and the Informed Consent Form, underscoring the need for expert guidance.
Tailoring regulatory strategy to the desired target product profile: Whether dealing with chemical entities or biologics – necessitates a tailored regulatory approach.
Navigating the complex landscape of diverse investigational drugs, medical devices and therapies involving genetically modified organisms requires proactive regulatory leadership, oversight and strategic thinking.
Pharmacovigilance considerations
Safety reporting requirements are standardised globally, but the process by which this data is communicated can vary significantly from region to region. From format disparities to upcoming changes like electronic filing systems, being prepared to navigate these intricacies is paramount to trial integrity.
Navigating EMA XEVMPD: The European Medicines Agency’s eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) is pivotal in safety reporting. Establishing the EudraVigilance setup early is essential, as it is otherwise not possible to enter into the XEVMPD system.
With the advent of the Clinical Trial Information System (CTIS), active substances and new development medicinal products (DMP) to be used in a clinical trial must be entered in the XEVMPD by the sponsor organisation as a prerequisite for a clinical trial application.
Reference safety information: A clearly defined ‘reference safety information’ section in the Investigator’s Brochure is indispensable. Meeting the stringent criteria for expectedness determination in the UK and EU requires thorough documentation and medical rationale alignment.
Key to Success
The complexities involved in global clinical trials are better managed with the help of an experienced partner who can provide guidance and navigation throughout the process.
Strategic partnerships enable sponsors to navigate the intricacies of regulatory compliance and safety considerations with confidence, ensuring seamless trial execution and optimal patient outcomes.
Early engagement with regulatory agencies: Proactive engagement with regulatory agencies fosters a collaborative approach to drug development, expediting the journey of groundbreaking treatments to patients.
Quality and compliance mindset: Infusing a culture of regulatory compliance and safety vigilance from the trial’s outset is non-negotiable. Partnering with an experienced clinical research partner ensures successful oversight and delivers positive outcomes.
In conclusion, success in global clinical trials hinges on trusted, flexible and strategic partnerships, combined with meticulous planning and regulatory compliance.
Mai Yee Mishir is Senior Director, Global Regulatory Affairs and David Turner is Senior Director, Global Safety Services at Advance Clinical.
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