PR No.144 Islamabad: 27th July 2018

Federal Minister National Health Services Muhammad Yusuf Shaikh said the importance of strengthening Health in a country cannot be undermined. As a part of social development, Health sector and its allied disciplines need special attention for ensuring timely availability of Health facilities to the fellow citizens. Government of Pakistan is continuously investing its resources and aim at providing sufficient health care facilities in the country. The availability of quality and safe medicines is the essential component of this system. The effective regulation of medicine, medical devices and biologicals among others enable the society to take benefit of quality assured and safe medicine. Drug Regulatory Authority of Pakistan (DRAP) has been mandated to regulate therapeutic goods and it is essential that such international practices that will enhance its functions. while he was addressing the Integrated Regulatory Information Management System today in Islamabad. Minister said the enhancement of its regulatory functions can be achieved more effectively using advanced, state of the art and internationally accepted practices including harmonized information management system. The implementation of this software for integration of all data related to regulatory functions of DRAP in one system will help to improve the access to safe effective and quality medicine. It will improve performance efficiency of DRAP by decreasing the lead processing time of applications, ensuring transparency, integrity and strengthening of communication among regulators, industry and people. He said it is also necessary to harmonize the functions of DRAP with stringent regulatory agencies around the globe. It will boost the export volume of quality and safe pharmaceutical products to more regulated markets which will ultimately benefit the foreign exchange resources of the country. The robust systems and ease of business will attract new investments in the field of pharmaceutical manufacturing. Minister said accordingly, Implementation of Integrated Regulatory Information Management System (IRIMS) is a success of DRAP in updating its systems in accordance with modern technological needs. Minister expressed his pleasure that DRAP has adopted such system and is committed to ensure access to affordable quality assured, safe and efficacious medicine to the people. It is a process of continual improvement and I encourage DRAP to streamline its systems and processes. On this occasion Chief Executive Officer, DRAP said with technological advances and ease of access to information in this age, it has become mandatory to adopt computer assisted programs. The benefits of such computerized programs surpass all other modes of manual functioning. And there is no doubt that in order to meet today’s requirements of efficiency, effectiveness and management of huge amount of information and data, a software based system is necessary. CEO DRAP said the regulation of therapeutic goods is based on science and with every day advancements in the field, new technology, research practices evolve to ensure safety of patients. It is important to update our regulation and operations accordingly at par with international best practices. DRAP with its mandate to ensure quality assured safe medicine in the country has started to upgrade its systems along with updating its rules and regulations as a requirement of modern day needs for harmonization, transparency and effectiveness. It is the first time that a completely integrated international standard software is being deployed at DRAP which is specific to the functions of the Authority. CEO DRAP said it had been a necessity since long that decade old manual systems shall be converted to modern technologically advanced tools of information management. DRAP started its journey of computerization a long time ago and now most of the every day operations are performed electronically, however, there was a dire need for an international standard software to integrate all the essential regulatory information and data. A strategic approach is adopted for internationalization of DRAP’s operations and IRIMS is placed at the center of this approach. The need for harmonization of all regulatory functions as mandated by The DRAP Act, 2012 can be effectively fulfilled with adaptation of international best practices. DRAP’s ultimate objective for regulating therapeutic goods in the country will be supported by IRIMS and the efficiency and effectiveness of its operations will also increase. By deploying this software, DRAP is able to perform its functions of Registration, Licensing, quality control and inspections in an integrated manner. This software will manage all the record of activities, operations and functions performed by DRAP.A real time data of registered drugs, manufacturing licenses, and Laboratory and inspection reports could be generated and made available for regulatory decisions. CEO said implementation of IRIMS is one of various steps taken for ensuring availability of quality assured, safe and efficacious therapeutic goods in the country. In this spirit, DRAP is committed to enhance its management of regulatory requirements in the country. Our target in site is the attainment of World Health Organization level III compliance for a formal stable regulatory system for regulation of medicine. He said Certain things have been achieved in this regard for example updating of rules and regulations as per international requirements, preparation of guidelines, deployment of database, implementation of barcode, and adoption of CTD. WHO certification of CDL is almost near completion. Establishment of a Quality Management System at DRAP is in pipeline and extensive work has been done for increasing output of the existing system.

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