iSpeak Blog

Asia Pacific and Its Impact on the Global Pharmaceutical Industry

Vivien E. Santillan
Asia Pacific and Its Impact on the Global Pharmaceutical Industry - ISPE Pharmaceutical Engineering

The Asia Pacific (APAC) region is diverse in terms of its demographics. From the developed countries such as Japan, South Korea, Taiwan, Singapore, and Australia to emerging economy countries such as Thailand, Indonesia, Malaysia, Vietnam, Bangladesh, and the Philippines including China and India. Asia Pacific pharmaceutical market is the second largest in the world after North America. It is anticipated that by 2021, the Asia Pacific market will have increased its lead over Western Europe which is currently in third place. This is attributed to several factors – size of the population especially the older population, GDP per capita, health expenditures, regulatory systems, physicians’ attitudes as well as disease incidence.1 With these economic indicators, the pharmaceutical industry in the region is adapting to new technologies, innovation and digital transformation to become current in industry trends and to ensure that programs and initiatives in providing patient care become sustainable.

Most of the countries in Asia Pacific adopt and implement the PIC/S GMP guide. The Association of Southeast Asian Nations (ASEAN) comprising of 10 South East Asian countries, as part of its harmonization, created a Mutual Recognition Agreement (MRA) and agreed to use the PIC/S GMP as basis for the MRA.

With these developments in the pharmaceutical market in Asia Pacific, ISPE is set to launch its inaugural ISPE Asia Pacific Pharmaceutical Manufacturing Conference on 30 September – 1 October 2019 in Singapore with the theme Regulatory Insight on Drug Discovery, Approvals and Inspection Management. The conference will bring in global regulators and industry experts who will share their knowledge and expertise and discuss relevant topics facing the industry with practical and actual industry experiences and examples. The event will provide attendees with important information on the current trends in the pharmaceutical industry as well as equip them with better understanding to achieve sustainable quality that goes beyond compliance.

The 2-day 2019 ISPE Asia Pacific Pharmaceutical Manufacturing Conference will focus on global regulatory topics to understand quality, regulatory requirements and the expectations from the members of the industry. Regulatory experts from PIC/S, WHO, MHRA, US FDA, Japan PMDA, Singapore HSA and Philippines FDA will discuss topics on PIC/S GMP Inspection Reliance Initiative, how to have a robust quality risk management and how to achieve and maintain a matured quality culture.

Pressing issues and topics in the region focusing on quality and compliance requirements for an effective cleaning validation program, data integrity for manufacturing and process validation will also be discussed as well as perspectives from US FDA Regulators which are areas of concern during regulatory inspections. In addition, actual industry examples of OOS investigations and differentiation between root cause analysis vis-a-vis CAPA will also be discussed to help pharmaceutical companies learn how to establish a reliable and sustainable quality system. A session on Facilities of the Future with topics such as exploration of Pharma 4.0 and Pharma Society 5.0 will be presented by industry experts and Takeda Pharmaceutical, respectively. Finally, concepts on continuous manufacturing will be discussed by a professor from the University of Tokyo.

The closing plenary session will be something to watch out for as it will be an open dialogue with a panel of international regulatory experts to give insights on the global inspection and collaboration efforts from US FDA, EU, and PIC/S.

After the conference, participants may register for the 2-day in-depth training on GMP Fundamentals which will be led by featured speakers:

Carmelo Rosa, PsyD
Director, Division of Drug Quality I
FDA/CDER/OC/OMQ
Aditi S. Thakur
Acting Quality Assessment Lead
FDA/CDER/OPQ/OPF
Frank Verni, RPh, MPH
RPh, MPH, Compliance Officer
FDA/CDER/OC/OMQ

With the ever-changing landscape of the pharmaceutical industry, ISPE together with its affiliates in Asia Pacific, will remain to be at the forefront of delivering technical and operational solutions in the manufacture of quality medicines across the pharmaceutical industry in the years to come. Let us continue to be challenged, excited and inspired in the manufacture of better medicines and patient safety.


The 2019 ISPE Asia Pacific Pharmaceutical Manufacturing Conference features an unparalleled line-up of regulatory leaders, including more than 20 regulators presenting and attending from MHRA, WHO, USFDA, Philippines FDA, PIC/S, PMDA, and Singapore Health Sciences Authority. You’ll have the unique opportunity to tap into the minds of global regulatory decision-makers in drug discovery, approvals, and inspection management.

For a limited time, take 50% off the Conference or the 2-day training course by using promo code APAC50 during checkout.

Register Now!

  • 1. https://www.einnews.com/pr_news/441070478/asia-pacific-pharma-market-to-grow-at-over-8-a-year-to-2021-says-tbrc