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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5335_Библиотеки_им_академика_М_И_Перельмана.pdf
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
as its first Asian member augurs well for the establishment of HSA.
It will be included in the HSA Bill when it is tabled for reading in
Parliament.” Thus, when the HSA Bill 2001 was read in Parliament
sometime in the year 2000, indeed the Minister for Health cited
Singapore’s PIC/S accession as a very key achievement in support of
the establishment of HSA. The relevant portion of the speech by the
Minister for Health to the Singapore Parliament highlighting this
international PIC/S achievement — a first by an Asian country — is
exhibited on the previous page.
1.5.2. Advantages of PIC/S Membership to Singapore and Other Participating Authorities
PIC/S oers a variety of advantages to its Participating Authorities.
Some of the main benefits for the national medicines regulatory
authority and the industry resulting from PIC/S membership are
detailed below.
• Training opportunities: PIC/S provides a forum for the train-
ing of pharmaceutical inspectors, allowing them to benefit from
the increased training opportunities, professional interactions
and regulatory networking. These regular events include the
annual PIC/S Seminars, the Expert Circles and the PIC/S Joint
Visit Programme. The training programmes are co-organized
by individual PIC/S Participating Authorities in collaboration
with the PIC/S Secretariat. For example, the annual PIC/S Seminar 2023 was co-organized by the Thai FDA in collaboration
with the PIC/S Secretariat. This Seminar was held in Bangkok,
Thailand from 6 to 10 November 2023.
Evolution of Pharmaceutical Inspection in Singapore and Benchmarking to PIC/S
Annual PIC/S seminar 2023, Thailand
• International GMP harmonization: By taking part in the
biannual meetings of the PIC/S Committee of Ocials, the
annual PIC/S Seminars and Expert Circles, amongst others,
PIC/S Participating Authorities get to be involved in the development and harmonization of international GMP guides and
guidelines. The PIC/S Committee of Ocials also actively promotes the uniform interpretation of GMP and quality system
standards for pharmaceutical inspectorates.
• Networking: By attending PIC/S activities, participants bene-
fit from personal contacts with other agencies, whether they
are part of PIC/S or not. This networking often simplifies contacts and the exchange of GMP and quality-related information,
whenever the need arises. In addition, PIC/S events are amongst
the few international GMP forums where regulatory inspectors
get to meet together for networking and confidence building.
At these PIC/S events, regulatory inspectors (whether they are
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
Biannual PIC/S Committee of Ocials meeting
new GMP inspectors, specialist inspectors or chief inspectors)
assemble and brainstorm, discuss issues of mutual concern and
share their experiences and knowledge. In other international
forums, participation is often at the administrative and leadership levels, e.g., the International Coalition of Medicines Regulatory Authorities Heads of Agencies Meetings or the ASEAN
Pharmaceutical Products Working Group Meetings. At such
forums, there are little opportunities for GMP-related issues to
be discussed and articulated.
• High standards: PIC/S ensures that all Participating Author-
ities comply with PIC/S norms and standards, including the
PIC/S Quality System Requirements for Pharmaceutical Inspectorates, at all times. This is carried out through the assessment
of new PIC/S applicants and the reassessment of existing PIC/S
member inspectorates. Preparing for PIC/S accession and reassessment helps to instill a culture for inspectorates to always
Evolution of Pharmaceutical Inspection in Singapore and Benchmarking to PIC/S
operate a PIC/S-equivalent framework, and to continually
improve their GMP inspection system and licensing procedures.
• Sharing of information: PIC/S membership also facili-
tates more eective use of inspection resources through the
voluntary sharing of GMP inspection reports and qualityrelated information. Membership is also a cost-saving measure
for the inspection authorities which are often confronted with
an ever increasing volume of inspections, including inspections
of API manufacturing facilities located worldwide.
• Rapid Alert System: Through PIC/S membership, national
regulatory authorities (NRAs) automatically benefit from
being part of the PIC/S Rapid Alert and Recall System; this system picks up quality defects of batches of medicinal products
which have been distributed to the domestic and international
markets. The PIC/S Alert and Recall System is part of a wider
system which includes the Alert and Recall System of the EU,
European Economic Area, and their Mutual Recognition Agreement (MRA) partners.
• Facilitating the conclusion of other Agreements: Membership
in PIC/S may also facilitate the conclusion of other agreements
such as the MRAs between PIC/S members at various levels,
e.g., Australia-Canada MRA, EU-Switzerland MRA, SingaporeAustralia MRA and the Singapore-New Zealand MRA on GMP
Inspection, Korea-Singapore MRA on Pharmaceutical GMP
Inspection as well as the ASEAN Sectoral MRA on GMP for
Manufacturers of Medicinal Products.
• Indirect Benefits for Industry
There are also indirect benefits to the pharmaceutical industry
when the relevant NRA becomes a member of PIC/S. These benefits may include the following:
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
— reduced duplication of pharmaceutical inspections;
— cost savings for both pharmaceutical manufacturers and
inspectorates;
— export facilitation for medicinal products across the world;
— enhanced market access for medicinal products.
Although PIC/S is not a trade agreement, membership of PIC/S
has helped to facilitate the export of medicinal products to international markets. Many non-PIC/S NRAs also accept GMP Certificates from PIC/S Participating Authorities. This means that
non-PIC/S NRAs and organizations have confidence in medicinal
products that are manufactured in countries where the NRA is a
PIC/S Participating Authority. Consequently, the pharmaceutical
industry located in these countries indirectly benefits from PIC/S
membership.
1.6. Emergence of MNC Pharmaceutical Manufacturing Industry in Singapore
Over the past three decades, Singapore had invested significantly
in the pharmaceutical sector, setting aside a dedicated biomedical
science hub in the western part of the island nation. Today, virtually
all the world-class pharmaceutical and biopharmaceutical manufacturing companies such as GSK, Lonza, Abbott, Roche, MSD, Amgen
and Pfizer have set up facilities at the Singapore Tuas Biomedical
Park. By the end of 2021, there was a total of 15 MNC manufacturers
of APIs and finished dosage forms located at the Tuas Biomedical
Park. Over the next few years, new manufacturing plants for mRNA
vaccines, bulk biological APIs, antibody drug conjugates, and filland-finish facilities, are expected to be set up in Singapore, also
Evolution of Pharmaceutical Inspection in Singapore and Benchmarking to PIC/S
at the Tuas Biomedical Park, and these include BioNTech , S an ofiPasteur, Thermo-Fisher, Hilleman Laboratories and AstraZeneca.
1.6.1. Why do MNC Pharmaceutical Manufacturers Set Up Facilities in Singapore?
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Pharmaceutical and biopharmaceutical manufacturers often decide
to set up facilities in Singapore for a number of good reasons, which
include the following rationale:
• Political Stability and Business-Friendly Environment
Singapore oers a stable political environment, transparent legal
system, and favorable business regulations, making it an attractive
destination for international investments. The government provides
various incentives, including tax holidays and support schemes to
encourage MNC pharmaceutical companies to establish operations
in the country.
• Strategic Location
Singapore is strategically located between the East and the West, providing easy access to a rapidly growing global market for medicinal
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
products. Singapore serves as a gateway to the Asia-Pacific region
which is one of the fastest-growing pharmaceutical markets globally. Asia is home to large economies such as those of China, India,
Japan, South Korea, Taiwan, Hong Kong and ASEAN.
• International Quality Standards and Medicines Regulatory
Framework
Singapore maintains high-quality standards for granting market
authorization together with a robust medicines regulatory framework for pharmaceutical manufacturing and distribution. Companies operating in Singapore benefit from HSA being the first PIC/S
Participating Authority from Asia, the first NRA in the world to
achieve WHO Global Benchmarking Tool Maturity Level 4, as well
as being a pioneer WHO Listed Authority.
• Advanced Infrastructure
Over the past decades, Singapore has built world-class infrastructure, including state-of-the-art research facilities, advanced manufacturing capabilities, and a well-developed transportation system,
comprising highly connected air, sea and road networks. This facilitates ecient production, distribution and exportation of pharmaceutical products.
• Highly Skilled Workforce
Singapore has a highly educated and skilled workforce, with a strong
emphasis on science, technology, engineering, and mathematics
(STEM) disciplines. Pharmaceutical companies can tap into this talent pool for research, development, and manufacturing operations.
• Intellectual Property Protection
Singapore has robust intellectual property laws and regulations, providing strong protection for patents, trademarks, and other forms of
Evolution of Pharmaceutical Inspection in Singapore and Benchmarking to PIC/S
intellectual property. This encourages innovation and investment
in research and development within the pharmaceutical and biomedical sectors.
• Access to Regional and International Markets
By establishing operations in Singapore, pharmaceutical companies
gain access not only to the local market but also to neighboring
markets in Southeast Asia, greater Asia and beyond. This enhances
their competitiveness and enables them to capitalize on the growing healthcare needs in the region.
Overall, the combination of strategic location, advanced infrastructure, political stability, supportive business environment, highly
skilled workforce, intellectual property protection, international
medicines regulatory framework and high-quality standards, and
access to regional markets makes Singapore an attractive destination for manufacturers of medicinal products.
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1.7. Immediate Spin-Os from Singapore’s PICS
Membership — Conclusion of MRAs
With membership of PIC/S in 2000, Singapore is in a position to
pursue MRAs with other PIC/S countries, beginning with Australia.
An MRA on GMP Inspection was negotiated, concluded and signed
between the Governments of Singapore and Australia on 26 February 2001. The signing of the Singapore-Australia MRA on GMP
Inspection meant that the TGA of Australia now accepts the GMP
inspection reports and GMP Certificates issued by the HSA of Singapore and vice versa. With eect from 2020 and 2024, Singapore
had also signed MRAs on GMP Inspection with New Zealand and
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
South Korea respectively. The status of Singapore as a regional life
sciences and pharmaceutical hub has been enhanced considerably,
and global acceptance of the quality of pharmaceutical products
manufactured and exported from Singapore can also be expected.
Overall, and in the longer term, the pharmaceutical manufacturing
industry in Singapore can look forward to easier access for their
products to export markets in Australia, New Zealand, South Korea,
Europe and other parts of Asia and the world.
From the year 2000 onwards, the ASEAN pharmaceutical industry
and regulatory community took notice of the PIC/S membership of
Singapore. Overall, ASEAN Member States were inspired and they
looked towards HSA for leadership to drive ASEAN harmonization
on pharmaceutical inspection using the PIC/S inspection framework as the benchmark for the region. This is covered in Chapter 2.
Chapter 2
ASEAN Harmonization on Pharmaceutical
Inspection and Mutual Recognition
Arrangement Implementation
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2.1. Benchmarking to the Pharmaceutical Inspection
Co-operation Scheme (PIC/S)
ingapore became the first Asian member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) on
1 January 2000. A year later in 2001, Mr. Robert (Bob)
S
the PIC/S Chairman for the term 2000 to 2001, invited Mr. Sia
Chong Hock (co-author) to join in the PIC/S team to assess the medicine regulatory authority of Malaysia. At that point in time, the
co-author was the Head of the GMP Audit Unit in Singapore, and
Malaysia had just submitted an ocial application to join PIC/S.
The co-author recalled: “Bob Tribe and I worked together very
Tribe, the Rapporteur for Singapore’s PIC/S accession and