19th International Conference of Drug Regulatory Authorities

العربية                   中文                   Français                    Русский                    Español

Message from Dr Rogério Gaspar, Director, WHO Regulation and Prequalification

Celebrating the success of the 19^th ICDRA

The 19th ICDRA was held from 14–18 October 2024 in New Delhi, India. The theme was Smart Regulation: Delivering Quality Assured Medical Products for All. This event was hosted by the Central Drugs Standard Control Organization, the national regulatory authority of the Government of India. It gathered close to 700 global regulatory leaders and 160 representatives from industry, procurement agencies, product development partnerships, NGOs, academia and others to discuss advanced approaches to ensure access to safe and effective medical products worldwide.

The pre-ICDRA conference was opened with a keynote speech by Malebona Precious Matsoso, Co-chair of the WHO Intergovernmental Negotiating Body. Official opening remarks were from officials, including Jagat Prakash Nadda, Union Health Minister, Government of India and Dr Tedros Adhanom Ghebreyesus, Director-General of WHO. They emphasized the critical role of regulatory convergence, harmonization and collaboration.

Pre-ICDRA discussions highlighted the WHO Listed Authorities (WLA) framework, stressing its benefits for regulators, industry and patients. Stakeholders discussed new reliance opportunities and shared ideas for enhancing regulatory collaboration and efficiency under the WLA framework.  Another session considered the role of WHO’s Prequalification in public health. It presented new initiatives like expanded pathways, parallel guideline development and Coordinated Scientific Advice for improving medical product standards and regulatory processes.

Workshop sessions focused on critical areas such as:

• sustainable local production of quality assured medical products;
• regulatory systems strengthening through partnerships;
• pharmacovigilance;
• substandard and falsified medical products, traceability of products;
• facilitated product introduction pathways;
• quality of pharmaceutical starting materials;
• regulation of advanced therapy;
• dependence on animal studies;
• access to medical devices (including in vitro diagnostics) through prequalification;
• reliance;
• updates on the African Medicines Agency.

These workshops fostered collaboration and knowledge-sharing among stakeholders on medical product safety, supply chain integrity and regulatory effectiveness.

ICDRA highlights: advancing regulatory practices and preparedness

The Pre-ICDRA activities transitioned into the main ICDRA conference. After the opening ceremony, Kimberlee Trzeciak, Deputy Commissioner of the U.S. Food and Drug Administration, delivered the keynote address. Key discussions included updates on the implementation of recommendations from the 18th ICDRA and several plenary sessions focused on advancing global regulatory practices.

The first session emphasized the need for harmonization in regulatory science. It explored reliance as a means of facilitating collaboration and the role of regulatory networks in supporting convergence through joint activities, such as inspections and assessments. Discussions aimed to identify best practices, challenges and solutions.

The second session focused on good regulatory practices, particularly in revising the Global Benchmarking Tool (GBT) indicators based on diverse applications and stakeholder feedback. Emphasis was placed on the WLA framework, aiming to improve access to medicines.

The third session focused on global and regional regulatory trends for medical devices. It emphasized the importance of cohesive strategies to strengthen regulatory frameworks across regions and to address variability in regulatory requirements.

The final session concluded with a review of the COVID-19 pandemic's impact on regulatory preparedness. It highlighted valuable lessons learned and provided key recommendations to enhance readiness for future health emergencies.

Recommendations were developed for Member States and WHO.

Strengthening global regulatory frameworks

A series of workshops focused on strengthening global regulatory frameworks, enhancing collaboration and exploring innovative solutions for pharmaceutical oversight.

The session on strengthening national control laboratories highlighted the role of laboratory networks in supporting national regulatory authorities. Discussions emphasized sharing best practices, enhancing quality control, and making recommendations for reinforcing regulatory systems for medical products.

A session on clinical trials explored World Health Assembly resolutions, guidance from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and the Declaration of Helsinki. It focused on promoting harmonized practices in clinical trial regulation.

Regulation of traditional medicines was another focus area. This session addressed unique challenges in quality control, standardization and pharmacovigilance. Recommendations encouraged integration of traditional medicines into regulatory frameworks and proposed paths forward.

The quality management systems (QMS) session examined various approaches to implementing QMS across diverse regulatory settings, addressing key challenges and proposing solutions. Another session on norms and standards focused on post-approval changes for medical products, where participants explored strategies on harmonizing global practices.

Another session examined the use of artificial intelligence and machine learning for detecting substandard and falsified medical products. It focused on global implementation challenges, feasibility and prioritizing patient safety.

A session on regulating medicines for pediatric and under-represented populations highlighted recent progress in developing drugs for children and addressing the needs of pregnant and lactating individuals. Discussions emphasized the importance of collaboration among regulatory authorities, particularly through the Pediatric Regulatory Network. Good practice (GxP) inspections were also discussed, exploring smarter regulatory practices, risk-based approaches, and the possibility of creating a regulatory network for GxP inspection guidelines.

Another session reviewed the role of regulatory information management systems, highlighting gaps in current systems and exploring the potential of artificial intelligence integration to bridge these gaps. Antimicrobial resistance (AMR) was also discussed, urging increased international collaboration to contain AMR progression and implement robust policies globally.

These sessions underscored the importance of regulatory convergence and harmonization, highlighted the benefits of technology integration, and emphasized the value of collaborative approaches across the regulatory landscapes to strengthen global public health.

Recommendations for strengthening regulatory systems

The conference concluded with actionable recommendations for WHO and Member States, emphasizing continued cooperation among regulatory authorities and WHO to advance smart, efficient regulatory practices worldwide. These recommendations addressed topics such as:

• promoting collaboration and exchange to encourage dialogue among national regulatory authorities, including fostering information exchange on regulatory matters, new health products and best practices;
• strengthening regulatory systems to support countries in building and enhancing their regulatory systems, focusing on improving standards for approval of products, quality assurance and safety monitoring;
• addressing global health challenge of substandard and falsified medical products, particularly in low- and middle-income countries;
• harmonizing standards towards global alignment on regulatory standards to reduce disparities and ensure consistent safety and quality requirements for medical products;
• encouraging innovation and accessibility to promote regulatory frameworks that support access to essential medicines, innovative treatments and vaccines, especially in under-resourced regions.

ICDRA content and recommendations will soon be available on the WHO website.