The new article highlights the aspects related to the conditions to be fulfilled for a reliance mechanism to be applied and also describes its key components.
The Drug Regulatory Authority of Pakistan (DRAP), a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the reliance mechanism in regulatory processes. The document describes in detail the DRAP approach on Good Reliance Practice. In particular, the authority explains the situations when it may rely on decisions made by other national regulating authorities when making decisions with respect to medical devices and other healthcare products intended to be marketed and used in Pakistan. The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding changes to the underlying legislation.
Reference Regulatory Authorities
As it was mentioned before, when applying a reliance approach, the authority actually relies on the assessment conducted by a foreign national regulating authority. In this way, DRAP expects to facilitate the regulatory procedures, reduce the unneeded regulatory burden for the medical device manufacturers interested in placing their products on the country’s market, and also to ensure better allocation of review resources of the authority itself. First of all, DRAP acknowledges that well-resourced National Regulatory Authorities (NRAs) having robust drug regulatory mechanisms are more efficient in performing their regulatory functions and may be designated as reference regulatory authorities (RRAs) to meet the challenges of globalization, increasingly complex technologies and growing public expectations of faster access to novel therapies. As further explained in the document, when reliance mechanisms are applied, DRAP relies on decisions of reference regulatory authorities to ensure the safety, efficacy, and quality of therapeutic goods for robust and accurate decision-making about their own products, considering that the products registered and sold in the countries of reference regulatory authorities fulfill the harmonized standards. At the same time, the authority additionally emphasizes that the actual scope and extent of application of the reliance approach could differ significantly depending on the categories of therapeutic goods.
It is also important to mention that the scope of applicability of the reliance approach is not limited to the initial pre-market assessment – the same principles could also be applied with respect to post-marketing surveillance. In particular, in such cases, DRAP will rely on the well-established and efficient surveillance and reporting mechanisms introduced by foreign regulating authorities, meaning that the new information they will collect with respect to the safety and effectiveness of healthcare products will be considered by DRAP as well.
Marketing Authorisation of Pharmaceutical Drugs and Biological Products: Key Points
According to the document, pharmaceutical drug products and biological drugs are subject to review by the PE&R and BE&R Divisions of the authority respectively. In particular, registration itself is performed by the Registration Boarding in accordance with the Drugs (Licensing, Registering & Advertising) Rules 1976 establishing the general principles for drug registration in line with the applicable criteria related to their quality, safety, and efficacy. As set forth by the aforementioned Rules, the Registration Board shall, before registering a new drug for which the research work has been conducted in other countries and its efficacy, safety, and quality has been established therein, require the investigation on such pharmaceutical, pharmacological and other aspects, to be conducted and clinical trials to be made as are necessary to establish its quality and, where applicable, the biological availability, and its safety and efficacy to be established under the local conditions.
In accordance with the same Rules, the list of trusted jurisdictions includes the USA, European Union Countries, Canada, Japan, and Australia. The regulatory decisions of their respective authorities could be taken into consideration by DRAP when applying the reliance approach. This includes, inter alia, the decisions taken by the aforementioned authorities with respect to:
- Approval of healthcare products for marketing and use;
- Withdrawal of the product from the market or imposing any restrictions on the supply;
- Notifying about any adverse events associated with the product in question.
Hence, DRAP will rely on the regulatory information deriving from another national regulating authority in order to facilitate the regulatory procedures while ensuring any and all healthcare products allowed for marketing and use in the country are compliant with the applicable regulatory requirements.
Reliance Mechanism: Application and Components
As further explained in the guidance, the reliance could be applied provided that:
- The product in question is approved by the foreign national regulating authority and is considered safe and effective when used for its intended purpose;
- In the case of a drug substance, the particular dosage is considered safe;
- There is an MoU in place between DRAP and World Health Organization concerning collaboration in the context of the registration process.
According to the guidance, the reliance mechanism employed the following components:
- Review of public assessment reports, summary of product characteristics and labeling information;
- Recognition of reported safety and efficacy concerns of already registered medicines;
- Review of Certificate of Pharmaceutical Products (CoPP);
- Certificate of suitability issued by the European Directorate for the Quality of Medicines (EDQM);
- In case information is not available on the official website, the reference regulatory authority is contacted directly via electronic mail for a query or clarification on a particular issue under consideration;
- Regulatory status or any other regulatory information available in the public domain through their website.
In summary, the present DRAP guidance is intended to provide a better understating of the reliance approach and the way it could be applied in order to streamline the regulatory procedures and reduce the time needed to make new products available on the market while ensuring their safety, proper quality, and efficacy. The guidance describes in detail the circumstances under which a reliance mechanism could be applied and also outlines key components thereof.
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