The article describes the general principles outlined in the respective policy adopted by the authority and explains the approach the authority intends to apply.
The Drug Regulatory Authority of Pakistan (DRAP), a country’s agency in the sphere of healthcare products, has published a guidance document dedicated to the reliance mechanism in regulatory processes, i.e., “DRAP Approach on Good Reliance Practice”. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be considered by medicines and medical device manufacturers in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, and could be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations.
In particular, the scope of the guidance covers the reliance activities in the field of regulatory oversight of therapeutic goods, addressing regulatory functions spanning the full life cycle of a therapeutic product – namely registration and marketing authorization, pharmacovigilance, surveillance, regulatory inspection, laboratory testing, clinical trials oversight, and NRA lot release. The document describes in detail the respective policy adopted by the authority, including the applicable criteria, processes and mechanisms related to the use of a reliance pathway in order to facilitate certain regulatory decisions – for instance, by taking into consideration the results of an assessment conducted by a foreign regulating authority in the sphere of healthcare products or trusted institutions when making regulatory decisions for the products intended to be marketed and used in the country.
The purpose of the guidance is to assist in understanding the reliance approach and its key principles by the parties involved, and also to describe the mechanism intended for the actual implementation of the said approach when making regulatory decisions with respect to various therapeutic goods subject to marketing authorization and regulatory oversight in accordance with the existing regulatory framework. The said approach is intended to facilitate the regulatory decision-making process while ensuring the safety, efficacy, and proper quality of therapeutic products allowed for marketing and use in the country. The approach described in the guidance applies to various categories of therapeutic goods, such as medicines, biologicals, medical devices, and others.
In the course of its activity, DRAP is intended to ensure that any and all therapeutic goods placed on the country’s market are compliant with the applicable requirements and standards. For this purpose, the authority undertakes a wide range of activities including, inter alia, marketing authorization, and post-marketing surveillance and oversight. The authority also conducts a continuous analysis of the new information becoming available and reviews its policies and approaches based on the findings in order to ensure that emerging concerns are properly addressed. The DRAP acknowledges the increasing importance of effective collaboration with other national regulating authorities so that innovative, efficient, and safe medicines and medical devices become available to healthcare professionals and patients in a timely manner. The authority routinely analyses best practices and approaches adopted by the foreign regulating authorities in the sphere of healthcare products, and implements them as well in cases when it is beneficial from a public health protection standpoint. The reliance approach described in this guidance is one of such approaches widely used by the National Regulating Authorities (NRAs) of various countries. As explained in the guidance, DRAP has adopted reliance approach to improve its working efficiency based on the unilateral mutual recognition pathways leveraging regulatory work of trusted regulatory authorities to reduce its workload with independent decision-making.
The authority further explains that the proper implementation of an efficient regulatory system requires both significant human and financial resources. Furthermore, the continuous development of technologies used in the sphere of healthcare products and their increasing complexity creates requires the regulating authorities to be even more efficient to be able to ensure the safety, proper performance, and quality of medicines, medical devices, and other therapeutic goods. In response, national regulating authorities should continuously take the steps to improve the effectiveness of the regulatory processes and procedures they employ to ensure the proper concentration of regulatory efforts and allocation of resources. As a part of this process, the authorities may apply the reliance approach which provides This process is in line with the Good Regulatory Practices (GRP) that are being continuously improved by all the authorities, it is also beneficial for healthcare professionals and patients, and all other parties involved.
The increasing importance of cooperation among the national regulating authorities in the sphere of healthcare products has been recently confirmed by the pandemic caused by the outbreak of the Coronavirus Disease.
Terms and Definitions
The document also provides definitions of the most important terms and concepts used in the context of the reliance approach. The terms described in the guidance include, inter alia, the following ones:
- Abridged regulatory pathways stand for the regulatory procedures facilitated by the use of reliance, whereby the regulatory decision is solely or widely based on the application of reliance.
- Recognition (mutual) is a process which allows conformity assessments (of qualifications, product) carried out in one country to be recognized in another country.
- Reliance is an act whereby the DRAP takes into account and gives significant weight to assessments performed by another NRA or trusted institution or reference regulatory authority, or to any other authoritative information in reaching its own decision. At the same time, it is important to mention that DRAP remains independent, responsible, and accountable regarding the decisions taken, even when it relies on the decisions and information of others.
Apart from the ones described hereabove, the document provides definitions of such terms as “assessment” and “Reference Regulatory Authorities”.
In summary, the present DRAP guidance provides an overview of the reliance approach, explains the idea behind it, and describes the way it can improve the regulatory decision-making processes and make them more efficient. The document also contains definitions of the most important terms and concepts used in the context of the reliance approach.
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