Regulating Medicines in a Globalized World The Need for Increased Reliance Among Regulators (2020) / Chapter Skim
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6 The Way Forward
6 The Way Forward
Pages 89-96
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From page 89... ...
In particular, the committee believes public health would benefit greatly from more regulatory cooperation in the area of medicines safety and suggests further exploration by regulatory authorities and other stakeholders within the areas of pharmacovigilance (PV) and post-market surveillance.
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From page 90... ...
These suggestions included • proactively sharing post-market safety data; • establishing standards for timeliness and minimum information content for posting emergent safety issues or regulatory actions; • standardizing good pharmacovigilance practice (GPvP) , including roles and responsibilities of industry in collecting and reporting foreign safety data; and • encouraging reliance/work sharing throughout a product's life cycle, in the monitoring of PV, manufacturing quality, and post- authorization safety and efficacy.
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From page 91... ...
EXPANDING MUTUAL RECOGNITION AGREEMENTS TO GO BEYOND GOOD MANUFACTURING PRACTICE In Recommendation 4 in Chapter 5, the committee encourages regulatory authorities in the United States and in the EU to consider "the potential for expanding the EU-US MRA to include reliance in areas beyond GMP and a broader scope of products under the current GMP provisions." The committee was intentional in this wording. The committee saw no drawbacks in "considering the potential," nor did it hear negative comments about expanding the scope of recognition and reliance throughout the information gathering for this study.
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From page 92... ...
For more distant consideration, collaborative arrangements between the two regulatory authorities in reviewing such innovations as gene therapies and some newer cutting-edge modalities might also be explored. EVALUATING PUBLIC HEALTH IMPACTS OF RECOGNITION AND RELIANCE The committee looked at its sixth recommendation (see Chapter 5)
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From page 93... ...
FINAL THOUGHTS It is the committee's hope that its landscaping of the medicines regulatory environment will better position regulators, policy makers, and technical and public health experts to address some of the 21st-century challenges facing national leaders around the world in ensuring safe and effective medicines for their countries' people. As outlined in Chapter 2, these challenges range from ramifications of globalization, to drug shortages, to disease outbreaks.
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From page 94... ...
Well-resourced regulatory agencies are well positioned to grapple with the challenges posed by continuing innovations in medicine and technology, such as gene therapies and other advanced therapeutics for regulators charged with ensuring the quality, safety, and efficacy of cutting-edge medicines. Nonetheless, shared access to specialists with expertise in highly technical product research, development, manufacturing, and production could help even the well-resourced regulatory agencies stay abreast of the rapidly evolving science of medicines.
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From page 95... ...
Access to financial and human resources is highly variable, as are population characteristics because of variations in genetics and environmental exposure to health risks, cultural practices, burdens of disease, social perspectives, health care systems, demographics, and societal income levels. Despite all of these differences, however, the tie that binds the work of all medicines regulators is their mandate to facilitate and help ensure the availability of quality-assured, safe, and effective medicines to serve the public health.
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