Regulating Medicines in a Globalized World The Need for Increased Reliance Among Regulators (2020) / Chapter Skim
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3 What Policy Makers Need to Know About Today's Regulatory Environment
3 What Policy Makers Need to Know About Today's Regulatory Environment
Pages 37-54
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From page 37... ...
. Cooperation and collaboration in their many forms represent tools regulatory authorities can use to overcome resource constraints, avoid duplication of efforts, and leverage expertise across borders for improved decision making within a local jurisdiction or region.
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From page 38... ...
From a global perspective, the resources and expertise needed to assess the expanding number of complex medicines are limited. Complete execution of recognition and reliance arrangements will be essential if regulatory authorities plan to assess the broad spectrum of medicines being manufactured in a timely and reliable way.
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From page 39... ...
In this report, regulatory work products -- administrative documents produced by a regulator as a result of a regulatory authority's evaluation -- are differentiated from medical products that include but are not limited to medicines. These work products might include an inspection report or certificate of compliance for GMP, official batch release, or an assessment report regarding the evaluation of the clinical and statistical elements of the product clinical dataset used in the application requesting approval to market a new medicine.
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From page 40... ...
Of note is that none of the current MRAs include provisions for GMPs for advanced therapy medicinal products, although this may be an area of future interest between the United States and the EU. Before countries sign MRAs, their regulatory authorities spend a significant amount of time evaluating each other's systems and procedures to attain a level of confidence in each other's output.
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From page 41... ...
Under MRAs, partner regulatory authorities are not required to take the same enforcement actions in response to an inspection report; however, given the MRA precondition of regulatory authority equivalence, authorities in an MRA are expected to take enforcement actions that are congruent with and imply similar reactions to noncompliant practices. At the same time, it should be understood that action taken to suspend manufacturing activities at a site in 1 21 CFR § 26.1.
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From page 42... ...
Having an MRA or other agreement that facilitates waiving batch testing in the importing country or mutually recognizes official batch testing reduces costs and product wastage and allows importers and regulatory authorities to redirect resources toward areas of greater risk instead of performing redundant regulatory laboratory testing (Garbe et al., 2015)
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From page 43... ...
SOURCES: EMA, 2019f; EudraLex, Volume 4, EU Guidelines for Good Manufac turing Practice for Medicinal Products for Human and Veterinary Use, Annex 16: Certification by a Qualified Person and Batch Release. testing conducted prior to the approval of a medicinal product through strict guidelines for generating quality-assured and reliable test data while using an environmentally safe and animal numbers reduction approach (OECD, 2019)
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From page 44... ...
Thus, while GCP is not part of the recently functional EU-US MRA for pharmaceuticals, it is possible that the associated regulatory authorities could move beyond trust building and knowledge sharing and agree to expand the operational scope of the MRA to include recognition of each other's GCP inspections of clinical trials. Doing so could help repurpose both agencies' finite human and financial inspection resources.
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From page 45... ...
The Working Group's regular interactions provide a forum for strengthening relationships among the peer groups from the regulatory authorities. Because of the large number of redactions common with FDA inspection and assessment reports, a "super confidentiality commitment" (Super-CC)
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From page 46... ...
Regulatory authorities' strategies for responding to this public health need include expedited inspections and/or reviews of existing manufacturing sites or new sites (FDA, 2019c)
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From page 47... ...
Examples of such impediments vary, and might include unusable overly redacted inspection and assessment reports, lack of common formats or standards or conformity, insufficient human and financial resources, conflicts of interest, and insufficient authority granted to regulators entering into informal and formal recognition or reliance arrangements. For regulatory authorities to build further upon their current recognition and reliance activities, impediments to entering into and using informal and formal recognition and reliance arrangements need to be removed.
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From page 48... ...
Doing so would uphold the personal privacy protection laws in most jurisdictions and maintain and protect the social contract made with clinical trial participants while facilitating information sharing and optimal execution of recognition and reliance arrangements. Impediments Between Regulatory Authorities and Industry The suggestion to ease current redaction practices may contravene current interpretations of trade secret and confidentiality laws in some jurisdictions.
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From page 49... ...
Clearly, avoiding the generation of redundant data for regulatory decision making is one of the main foci of these reliance arrangements. Thus, the receiving regulatory authority exercises sovereignty, interpreting information provided by other regulatory authorities in conjunction with its own information and within the context of the local health care system and public health state of play.
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From page 50... ...
to help China implement international GMP, it appears that the manufacturing of falsified or substandard medicines and fraudulent clinical and manufacturing data remain challenges in many less resourced manufacturing sites (EMA, 2019d; Rees, 2019a; UNODC, 2019)
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From page 51... ...
However, the establishment of a strong system of reliance can build a network of trusted experts from different agencies that can be drawn upon for their valuable insight when a product development or assessment challenge arises that has not previously been encountered or addressed. The Need for Mutual Recognition of Third-Country Inspections Given the large number of manufacturing sites in China and India that are involved in producing drug components and/or final products for the United States and Europe, it has not been possible for either FDA or EMA to inspect all of these sites as they would like to do in order to assure the quality of products being exported to their people.
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From page 52... ...
of all API sites of interest to all those participating in the program formed the foundation for a mapping exercise carried out by the International Coalition of Medicines Regulatory Authorities showing the API manufacturing sites of common interest. This information is currently stored in the secure European database for GMP and good distribution practice inspections and certification platform, EudraGMDP, where participating countries take responsibility for updating their own information.
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From page 53... ...
Also of note are the 944 recorded good manufacturing practice (GMP) inspections conducted over the 6 years at 458 sites (49 percent in India and 36 percent in China)
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