Islamabad: In a significant boost to Pakistan’s pharmaceutical regulatory system and international standing, the Drug Regulatory Authority of Pakistan (DRAP) has been admitted as an Observer to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), one of the world’s most influential bodies responsible for setting global standards for medicines, vaccines and pharmaceutical regulation.
The announcement was made during the biannual ICH Assembly meeting held in Rio de Janeiro, Brazil, where DRAP’s application was approved following an extensive evaluation process by the ICH Secretariat and Assembly. New Zealand’s medicines regulator Medsafe was also granted observer status at the meeting.
Chief Executive Officer DRAP, Dr Obaidullah, described the development as a major milestone for Pakistan’s healthcare and pharmaceutical sector, saying it reflected the authority’s continued efforts to strengthen regulatory systems and align with internationally harmonised standards for the quality, safety and efficacy of medicines and vaccines.
“This important milestone reflects DRAP’s continued commitment to further strengthening regulatory systems and aligning with internationally harmonised standards for the quality, safety and efficacy of medicines and vaccines,” Dr Obaidullah said.
He maintained that as an ICH Observer, DRAP would actively participate in global regulatory discussions, adopt international best practices and contribute to harmonisation efforts aimed at improving public health outcomes.
Established in 1990, the ICH brings together leading medicines regulatory authorities and representatives of the pharmaceutical industry from around the world to develop common scientific and technical guidelines for the development, registration and monitoring of medicines.
Its standards are used by major regulators including the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada and many others.
Experts believe DRAP’s admission to the forum is a significant step towards enhancing the credibility of Pakistan’s regulatory system and facilitating greater acceptance of locally manufactured medicines in international markets.
Regulatory officials said observer status would provide Pakistan with direct access to discussions on emerging global standards related to drug quality, clinical trials, pharmacovigilance, biosimilars, bioequivalence studies, real world evidence, medicines safety and advanced therapeutic products.
The move is also expected to support Pakistan’s ambitions to expand pharmaceutical exports by helping local manufacturers align their products and manufacturing processes with internationally recognised regulatory requirements.
According to ICH, the approval of DRAP and Medsafe as observers has increased the organisation’s membership to 25 members and 43 observers worldwide.
During the Rio Assembly, the ICH also approved its new Strategic Vision aimed at advancing public health through harmonised regulatory guidelines and reviewed progress on several key guidelines covering pharmaceutical quality, efficacy, safety, biosimilars, stability testing, patient preference studies, medicines for pregnant and breastfeeding individuals and real world evidence.
The Assembly further adopted the latest annex of the internationally recognised Good Clinical Practice guideline, discussed development of a digital collaboration platform for harmonised guideline implementation and reviewed progress in the global use of the Medical Dictionary for Regulatory Activities (MedDRA), which is currently available in 27 languages and used by regulatory authorities across more than 100 countries.
Dr Obaidullah said DRAP’s admission as an observer marked an important step in Pakistan’s journey towards regulatory excellence, greater global collaboration and improved access to safe, effective and high quality medicines for its people.
He maintained that although observer status does not confer full voting rights, it allows DRAP to closely engage with international regulators, participate in technical discussions and prepare for eventual advancement within the global regulatory harmonisation framework, a development that could further strengthen public confidence in Pakistan’s medicines regulatory system and support the growth of the country’s pharmaceutical industry.
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