The new article highlights the aspects related to the specific provisions of the current legislation by the device of which the reliance mechanism is implemented into the existing regulatory framework. The article also describes the main principles to be followed when applying the reliance mechanisms.

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. In particular, the document describes the DRAP approach to Good Reliance Practice. The document explains the way the approval granted by foreign regulating authorities may be considered when applying for marketing approval in order to reduce the regulatory burden and facilitate the respective regulatory processes and procedures. 


The scope of the guidance covers, inter alia, the aspects related to legal provisions for reliance. According to the guidance, to ensure early access to quality therapeutic goods and novel therapeutic opportunities, DRAP has adopted reliance mechanisms for various categories of therapeutic goods along with its variable scope, for which the safety and efficacy have already been confirmed by the reference regulatory authorities or when the clinical trial has been approved by well-resourced regulatory authorities. 


As it was mentioned in the previous article, a similar mechanism is widely used by other national regulating authorities. The initial idea behind the said mechanism is that a regulatory decision already taken by a foreign national regulatory agency with respect to a medical device in question will be taken into consideration by the DRAP when reviewing the application for marketing approval. 


The applicable legislation includes the DRAP Act, 2012, as well as the Drugs Act, 1976 which together establish a legal framework for the use of the reliance approach in the regulatory decision-making process. 

Functions of the Authority

First of all, the document outlines the functions of the authority in the context of the reliance approach. The general functions of the authority include:

  • Issuing guidance documents;
  • Ensuring the proper implementation of the internationally recognized standards, including, inter alia, good manufacturing practices, good distribution practices, and bio equivalence studies; 
  • Coordination of activities with other national regulating authorities. 


Special Rules Under DRAP Act 2012

The document further describes the requirements set forth under the existing legislation, namely, the DRAP Act 2012. In particular, Section 39 of the said act establishes that the Authority may, subject to the prior approval of the Federal Government, co-operate with any foreign authority or international organization in the field of health on the terms and conditions of any program or agreement for cooperation to which such authority or organization is a party, or pursuant to any other international agreement made or after the commencement of this Act. 


Requirements Under the Drugs Act 


Apart from the requirements introduced under the DRAP Act, 2012, the document describes the requirements established under the Drugs Act, 1976. According to Section 43 of the aforementioned act, the authority is entitled to prescribe conditions for registration of indentors, importers, wholesalers and distributors within Pakistan and any establishment within any foreign country engaged in the manufacture for export of a drug and prescribe conditions providing effective adequate means by arrangement with the Government of such foreign country or otherwise, to enable the licensing authority or the Registration Board to determine from time to time whether drugs manufactured in such establishment if imported or offered for import into Pakistan, shall be refused admission where the public interest so requires. 

Principles of Reliance 

The document also describes in detail the main principles of reliance. As explained by the DRAP, when deciding on a specific approach to be applied, it takes into consideration multiple factors related to the national healthcare system and existing regulatory framework, as well as various resources available. In this respect, the authority will also consider the relevant needs and the steps to be taken to increase the overall quality of regulatory decisions. As further stated by the authority, the reliance mechanism itself is intended to ensure an optimal allocation of resources in order to facilitate and streamline the regulatory processes. The DRAP mentions that reliance can lead to more evidence-based and better-quality decisions. At the same time, the authority additionally emphasizes that the respective provisions of the national legislation will be taken into account as well. 

The reliance mechanism is based on the idea of sharing the regulatory work conducted by the authorities, including the assessment or inspection conducted. According to the guidance, reliance can be unilateral, mutual, or multilateral. 

The document outlines the following key principles of the reliance: 

  • A risk-based approach which requires the authority to assess the risk in accordance with the respective risk management practices (e.g., taking into consideration a “low-risk” determination of the product performed by a foreign regulating authority);
  • Optimum use of the resources available stands for allocating the resources proportionate to the risks associated with the device subject to review while removing duplication and focusing on the elements that are critical in terms of safety and effectiveness;
  • Ensuring that the products are identical, or that all the existing differences are clearly indicated;
  • Ensuring compliance with the regulatory requirements set forth by the national legislation; 
  • Flexibility in adapting national procedures and approaches while ensuring that the devices intended to be marketed and used in the country actually meet the safety- and performance-related requirements they are subject to in accordance with the respective risk-based classification.  


In summary, the present DRAP guidance describes in detail the way the reliance mechanism and its application are reflected in the provisions of the respective regulation. The document outlines the applicable legislation and explains the approach to be applied. 



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