The new article covers the aspects related to the application of the reliance approach to specific categories of healthcare products and also provides an overview of the reliance procedures.
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 application of a reliance mechanism in regulatory processes. The document describes in detail how the DRAP approach to good reliance practice will be applied with respect to marketing approval for the new products to be supplied in the country. When applying the reliance approach, the authority relies on the decision taken by a foreign national regulating authority of a trusted jurisdictions. In such a way, the DRAP expects to facilitate and streamline the regulatory procedures, and also to reduce the regulatory burden faced by medical device manufacturers interested in marketing their products in the country.
It is also important to mention that the present guidance is non-binding in its legal nature, nor is intended to introduce new rules or impose new obligations, but rather to provide additional clarifications regarding the existing regulatory requirements, as well as recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance thereto. 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 regulations.
Registration of Alternative Products
The scope of the guidance covers, inter alia, the aspects related to the registration of alternative medicines subject to regulation under the Alternative Medicines & Health Products (Enlistment) Rules 2014. First of all, the authority mentions that the aforementioned rule does not provide specific provisions related to the reliance approach itself. At the same time, DRAP clearly allows the use of reliance mechanisms for the products of this category by stating the following:
The combinations having evidence of Free Sale in the country of origin along with proof of marketing in any of the reference regulatory authorities as adopted by the Registration Board shall be considered for enlistment under Alternative Medicines & Health & OTC Rules.
The authority further confirms that the list of trusted jurisdictions, the decisions of national authorities of which would be taken into consideration by DRAP is the same as in other cases.
According to the guidance, the reliance mechanisms include the following elements:
- Review of public assessment reports, summary of product characteristics and labeling information;
- Recognition of reported safety and efficacy concerns of already registered/enlisted alternative medicines and health products;
- 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.
Lot Release Certificate
The guidance also provides additional clarifications regarding the regulatory requirements that apply to Lot Release Certificates to be issued by the Federal Government Analyst of the National Control Laboratory for Biologicals. As it is mentioned by the authority, such a certificate is required for any and all human vaccines, blood products, and anti-sera in order for them to be allowed for marketing and use in the country. According to the guidance, currently, lot release certificate for imported consignment is based on reliance in the form of summary protocol review along with lot release certificate of the national regulatory authority of the exporting country.
Reliance Procedure: Key Points
The document also describes the reliance procedures and highlights the key points associated thereto. According to the guidance, the main purpose of the reliance approach in general is to facilitate the regulatory procedures by minimizing the duplication of efforts for all the parties involved, reducing the regulatory burden for the medicines/medical device manufacturers. Furthermore, it is also expected to improve the overall quality of the regulatory decisions taken with respect to healthcare products. Apart from that, when applying reliance mechanisms, DRAP will be able to use its resources more efficiently while ensuring the availability of healthcare products compliant with the applicable requirements in terms of safety, quality, and effectiveness.
As explained by the authority, the reliance approach is to be impelled with the following steps:
- Verification and review of reliance information. First of all, the authority will review the information related to the product in question based on the previous authorization by other national regulating authorities. According to the guidance, for registration, the product characteristics (use, dosage, precautions) should conform to that agreed in the authorization by the RRA, and for drugs substances, which are already registered by the reference regulatory authorities in a particular strength and dosage form are considered as safe and efficacious, while considering registration applicants of new drugs in local perspective.
- Additional documentation. While reviewing the request, the authority is entitled to request additional documentation and information it would reasonably need to complete its review. It is important to mention that in certain cases, local clinical trial data could be required. As it is stated in the guidance, in addition to the full assessment report from the RRA, the applicant shall be required to submit a full Clinical Trial application, full Application for Marketing Authorization, and full application for GMP inspection as required by the Authority’s guidelines before authorization of the application through the reliance pathway.
- Assessment based on reliance procedure. Once the authority will have all the necessary information, it will proceed with the review for the decision to be taken.
In summary, the present DRAP guidance describes the way the reliance approach should be applied in certain specific cases and also provides additional clarifications regarding the reliance procedure. The document highlights the key points to be considered by the parties interested in placing their products on the country’s market and outlines the main benefits of the reliance approach.
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