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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
3rd Korea-ASEAN Inspectors’
2nd Korea-ASEAN Inspectors’
Training Course
Training Course
24–28 June 2019
2018 Korea-ASEAN GMP conference
31 October to 2 November 2018
Due to the COVID -19 pandemic, the 2020 Korea-ASEAN Inspectors
Training was held on 27 November 2020 via video conference. The
theme of this training course was remote (virtual) inspection, and
there was a case study of a virtual inspection of Samsung Biologics
conducted by the Russian Health Authority. The themes of the 2021
and 2022 inspector training courses were “GMP Inspection Reliance”
and “GMP Assessment of API Manufacturers” respectively. The 2023
Korea-ASEAN Inspectors Training Course was held back-to-back
with the 2023 Korea-ASEAN Pharmaceutical GMP Conference; the
theme was Contamination Control Strategies. With the transition of the
COV ID-19 pandemic to endemic status, these were held as in-person and on-site events in Seoul from 18 to 22 September 2023. This
Korea-ASEAN GMP training program for pharmaceutical inspectors
Developing a Training and Continuous Training Program for ASEAN Inspectors
has been ongoing since its inception in 2017. By 2023, at least seven
Korea-ASEAN training courses had been successfully conducted.
The close cooperation between ASEAN JSC on GMP Inspection and
Korea MFDS in training ASEAN pharmaceutical inspectors provided both parties with opportunities to discuss deeper regulatory
and other related collaborations. Senior ocials from Korea MFDS
were invited regularly for dialogue sessions with their counterparts
at ASEAN JSC meetings. During these ocial meetings, South Korea
had expressed strong interest in working towards an MRA on GMP
inspection with ASEAN Member States. At this point in time, not all
the 10 ASEAN Member States are technically nor operationally ready
to discuss the subject of an ASEAN-Korea MRA on GMP inspection.
At present, there are five ASEAN Listed Inspection Services, with
only four being PIC/S Participating Authorities. Furthermore, bilateral or multilateral MRAs are negotiated under the larger platform
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Dr. Choi Heejung (Deputy Director of Korea MFDS) with Mr. Sia Chong Hock
(Chair of ASEAN JSC) — 2017, Thailand
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
of Free Trade Agreements. Moreover, an MRA can take a long time
to negotiate and to conclude. These negotiations will have to involve
not only inspectors and regulators, but also lawyers from the Attorney-General Chambers, as well as trade and industry representatives
from the respective ASEAN Member States. Considerations will have
to be given to pharmaceutical import and export volumes, political,
legal, social and other impacts on trade and services as a whole. In
a nutshell, a Korea-ASEAN MRA on GMP inspection was too big in
scope and implication, and beyond the jurisdictions of both ASEAN
JSC and Korea MFDS alone, to manage.
However, Dr. Choi Heejung, a deputy director at Korea
MFDS, and Mr. Sia Chong Hock, Chair of ASEAN JSC, persevered (see image on previous page). Both decided to approach
the subject of a potential MRA by taking “baby steps” which
were more within their respective control. The co-author
(Mr. Sia) recalled: “Sometime in early October 2019, Dr. Choi broached
the subject of whether South Korea could consider a bilateral MRA
on GMP inspection with Singapore to me personally. Wearing the
hat of a Singapore ocial, I informed her that Singapore (as a small
country) is always willing to consider partnerships and agreements,
and to work together with other like-minded countries for mutual
interests. But such a matter must be discussed at higher levels in both
countries. I requested Dr. Choi to send me an ocial email so that I
could surface this important matter to my senior management.” The
email was sent very soon after by Dr. Choi and acted upon promptly
by the co-author. In late October 2019, Dr. Choi made an ocial trip
to Singapore to start the ball rolling. “Through our perseverance, the
matter was followed through very quickly by the relevant authorities
in both countries.” It culminated in a Memorandum of Understanding (MoU) for GMP collaboration which was signed by the CEO of
Singapore HSA and Minister of Korea MFDS on 23 November 2019.
Developing a Training and Continuous Training Program for ASEAN Inspectors
The MoU signing ceremony was witnessed in person by none other
than the Prime Minister of Singapore and the President of South
Korea in Seoul. The photograph of the Singapore HSA-Korea MFDS
Pharmaceutical GMP MoU signing ceremony is presented.
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Minister of MFDS (right) and CEO of HSA (left) signed the Singapore HSA-Korea
MFDS Pharmaceutical GMP MOU on 23 November 2019
Following the MoU, dedicated collaboration and mutual learning
between both regulatory authorities have paved the way for further synergy, leading to the Korea-Singapore MRA on Pharmaceutical GMP Inspection. This bilateral MRA was signed between the
governments of Singapore and South Korea on 26 February 2024,
also in the city of Seoul. Perhaps, one day, a Korea-ASEAN MRA on
GMP inspection may come to fruition.
Signing of Korea-Singapore MRA on GMP Inspection
As mentioned, Singapore and South Korea signed a bilateral MRA
on GMP Inspection for Medicinal Products on 26 February 2024.
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
This legally binding MRA was signed on behalf of the respective
governments of both countries by the Chief Executive Ocer of
HSA, Dr Mimi Choong, and the Minister of MFDS, Oh Yu-Kyoung,
at the Shilla Hotel in Seoul, South Korea.
Minister of MFDS, Oh Yu-kyoung (right), and CEO of HSA, Choong May Ling (left)
signed the Korea-Singapore Pharmaceutical GMP MRA on 26 February 2024
Source: Korea Biomedical Review, 27 February 2024
The MRA will enable the mutual recognition of GMP certificates
and inspection outcomes of manufacturers of medicinal products
sited within the two countries. The key benefit is the reduction of
regulatory burden on the pharmaceutical and biopharmaceutical
manufacturers in Singapore and South Korea through the reduction of duplicative on-site GMP inspections by both regulatory
agencies. The MRA is expected to improve eciency by cutting
down the resources needed to assess manufacturing sites and will
facilitate trade and access to medicinal products for consumers in
both countries. The areas of cooperation between HSA and MFDS
will include the mutual recognition of each other’s GMP certificates
Developing a Training and Continuous Training Program for ASEAN Inspectors
for the manufacture of investigational medicinal products, APIs,
chemical pharmaceuticals, biopharmaceuticals (including biologicals) and herbal medicinal products.
At the request of an importer, exporter or authority (Singapore HSA
or Korea MFDS), the other authority is able to assess and certify
that a manufacturer is appropriately authorized to manufacture
the specified medicinal products or carry out the specified manufacturing operation. The other authority is also able to certify that
a manufacturer is subject to regular inspections by the authority of
the territory, and that the manufacturer complies with the PIC/S
GMP standard. In addition, either authority may request the right
to conduct its own inspections of manufacturing sites located in the
territory of the other authority in exceptional circumstances for the
purpose of health and safety.
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Dr Mimi Choong commented: “HSA has always had close working
ties with MFDS and I am pleased that we are able to strengthen the
relationship through this cooperation. It is a testament to the shared
commitment between the two national regulators as we continue
to protect public health and safety in our countries. I trust that this
collective dedication will pave the way for greater mutual support
and information exchange as we uphold the high manufacturing
and quality standards of medicinal products in our jurisdictions.”
Minister Oh Yu-Kyoung added: “I find it very meaningful to conclude
the GMP MRA here in Seoul with Singapore who became one of
WHO-Listed Authorities along with Korea based on the understanding and confidence of regulations of the two nations we built over
time. Signing the MRA will pave the way for timely supply of safer
and more eective medicinal products to the public by bilaterally
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
recognizing the results of conformity assessment of the two nations
based on mutual trust.”
It is hoped that following the signing and implementation of the
Korea-Singapore MRA on GMP Inspection, other ASEAN Member
States will see the clear benefits arising from such an arrangement.
Perhaps, similar MRAs may be signed in future between South
Korea and the other ASEAN Member States, beginning possibly
with Malaysia, Indonesia and Thailand whose national medicines
regulatory authorities are already Participating Authorities of PIC/S.
Ultimately, in the mid- to longer term, it is hoped that a pan-ASEAN
MRA on GMP inspection with South Korea, as well as other Asian
countries, particularly China, Japan and India, can materialize.
3.4. Collaboration with the Generics and Biosimilars Initiative (GaBI)
With more biopharmaceutical products, including biotechnologyderived medicinal products and biosimilars coming out of the manufacturing pipelines, it is timely to expand the scope of the ASEAN
Sectoral MRA on GMP Inspection to also include biologics and
APIs, both of which are currently outside the scope of the MRA.
At the point of signing the MRA in 2009, the scope of the ASEAN
Sectoral MRA on GMP Inspection covered only the manufacture
of pharmaceutical products in finished dosage forms. Preparatory
work to include biopharmaceuticals began in 2018. The first ASEAN
Overview Workshop on GMP for Biologicals/Biosimilars was held in
Da Nang, a seaside resort city in Vietnam on 5 August 2018. It was
organized by the Generics and Biosimilar Initiative (GaBI) in collaboration with ASEAN JSC on GMP Inspection. The participants
Developing a Training and Continuous Training Program for ASEAN Inspectors
1st ASEAN Overview Workshop on GMP for Biologicals/Biosimilars: Speakers’ faculty, Da Nang, Vietnam, 5 August 2018
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2nd ASEAN Educational Workshop on GMP for Biologics: Participants, Jakarta,
Indonesia, 18 December 2019
of this inaugural ASEAN-GaBI workshop included inspectors,
reviewers and analysts from all the 10 ASEAN Member States. The
speakers and trainers were experienced regulators and scientists
from the regulatory authorities, industry and the World Health
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
Organization. These trainers came from a wide array of countries
such as the UK, Switzerland, India, China and Singapore. The 2nd
ASEAN Educational Workshop on GMP for Biologics was held in
Jakarta at the Gran Mahakam Hotel on 18 December 2019, backto-back with the 28th ASEAN Pharmaceutical Product Working
Group. On the previous page are some photographs of the 1st and
2nd ASEAN-GaBI workshops on GMP for biologicals and biosimilars.
Arising from the collaboration between GaBI and the ASEAN
JSC on GMP Inspection in the co-organization of training workshops on biologicals, the co-author got to know Ms. Lasia Tang, the
Co-Founder of GaBI. The mission and vision of GaBI are highly commendable as they are important for regional and global advancements of biosimilars and biopharmaceuticals in general.
3.5. Pre-employment Training in Pharmacy and Pharmaceutical Science Schools
Given that many university students, especially pharmacy and pharmaceutical science graduates, would eventually join the pharmaceutical sector, it is important to expose these students to ASEAN
and international harmonization activities before they enter the
employment market. The ASEAN JSC on GMP Inspection continually strives to promote the initiatives and progress on ASEAN harmonization of pharmaceutical inspections to universities, tertiary
educational institutions, and academia as widely as possible. One
such opportunity was presented at the 2019 Association of Asian
Schools of Pharmacy (AASP) Pre-Conference held in Suwon, South
Korea, from 3 to 5 July 2019. The co-author, who was also Chair of
the ASEAN JSC on GMP Inspection, delivered a presentation and
Developing a Training and Continuous Training Program for ASEAN Inspectors
interacted with ASEAN and Asian students at the 2019 AASP event.
These students will be the future professionals and pharmaceutical
leaders of tomorrow. When the co-author was an adjunct faculty
of NUS, he also incorporated the topic of ASEAN harmonization
on pharmaceutical inspection and quality assurance of medicinal
products into the pharmacy modules for undergraduates of NUS.
National University of Singapore
pharmacy undergraduates
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2019 Association of Asian Schools of
Pharmacy (AASP) conference — Suwon,
South Korea