Pilot Project on Regulatory Harmonization for Single Global Guideline Underway in Asia Pacific

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Pharmabiz.com Jan 04, 2012

Pharmaceutical sector which is now toying with the concept of a single global regulatory guideline has kicked off an initiative in the Asia Pacific region. In the ASEAN region, 10 countries have come together to initiate the process of harmonization.

A pilot project is underway in the Asia- Pacific region to ensure regulatory harmonization. This covers the China-Japan-Korea Tripartite for a joint research project on ethnic factors in clinical trials. In the China-Taiwan region a cross-strait Medical and Healthcare Co-operation agreement is being developed. Taiwan has proposed for the APEC PER (Pharmaceutical Evaluation Report) Scheme.

The harmonization initiatives by WHO – United Nations, ICH – USA, EU and Japan, EC/EMEA – Members of European Union, PIC/S – 35 participating countries and PANDRH – Pan American countries are on track.

“A harmonized regulatory environment would reduce the time to market the product by eliminating undue or perhaps unjustified country-specific requirements. It would provide transparent requirements which simplifies market access and expedites patients’ access to new and innovative technologies,” stated Kaushik Desai, director, DIA India, vice president and chairman, Industrial Pharmacy Division, Indian Pharmaceutical Association (IPA).

“Further, a uniform international regulatory system would also reduce the cost to market a product. It reduces unwarranted, often contradictory guidelines and redundant applications of similar requirements which leads to different product definitions in various geographies, further complicates  follow-up and comparison of data on safety issues. Overall it would enhance the utilization of already stretched and limited human and financial resources. Facilitating cooperation among regulators and the industry in conducting activities like common audits and exchange of safety information can be leveraged on experience gained over time,” he added.

The creation of common requirements to address product life cycle development, manufacture  and post-market surveillance would considerably reduces the burden, complexity, and unpredictability to seek clearance. The setting up of a premarket evaluation, uniform quality system and common clinical safety performance would only drive efficiency in the system, pointed out Desai.

Going by the current demand for an increasingly global environment and the need to integrate national and international standards in a universally acceptable format for the participating countries would facilitate well-organized global drug development and local registration. While every regulatory agency across US, EU, Japan and Asia share the same objective of ensuring safety, efficacy and quality of drug product, the issue today is that legislations and regulations differ. This is where globalization would lead to   harmonization, said Desai.

So long individual country strategies saw little global cooperation. The regulations from US, EU and Japan dominated the pharma industry. There was also a serious lag in the development of medicines in Asia. But this scene has transformed creating a space for an increasingly harmonized environment for regulations. For instance, the growing multi-regional clinical trials have   increased discussions on acceptability of foreign clinical data and demand to bridge studies. Future regulations indicate need for a single global regulatory guideline. The move has the acceptance of global data and authority cooperation. Newer paradigms for the future are the harmonization of Good Manufacturing Practices which will enable effective consolidation in manufacturing activities. A single facility could begin catering to multiple regions and later to the entire world. The engines of change in the regulatory landscape have started chugging off with the US FDA - Pharmaceutical cGMPS for the 21ST century, ICH, Q8 –Pharmaceutical Development, Q9 - Quality Risk Management, Q10 - Quality Management System, Q11 - manufacture of drug substances and issue of New Dietary Ingredient Notifications, he said.

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