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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5855_Библиотеки_им_академика_М_И_Перельмана.pdf
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
“look to the future”. This initiative was formed to address common
challenges faced by the participating countries such as huge backlogs of product applications, high sta turnover, long registration
times, inadequate financial resources, and limited capacity to assess
certain types of products such as biologicals and biosimilars.
Acknowledging these common challenges, the heads of agencies of
ZaZiBoNa agreed to develop a work-sharing arrangement to meet
the objectives that included a reduced workload, reduction in timeline to registration, development of mutual trust and confidence
in regulatory collaboration, and to provide a platform for training
and collaboration in other regulatory fields. In establishing these
objectives, the ZaZiBoNa initiative sought to make ecient use of
limited resources to ensure timely access to quality-assured medicines by the public in the Southern African Development Community (SADC) region whilst at the same time building the regulatory
capacity of the NRAs.
It has been reported that the collaborative initiative began with the
first assessment session in October 2013. These assessments initially
looked at applications common to the four founding countries that
were pending in the backlog but expanded over time to review
products submitted prospectively. In 2014, the ZaZiBoNa initiative was formally endorsed and adopted by the SADC Ministers of
Health. Since then, the initiative has grown, and 14 of the 16 SADC
member countries are now participating either as active or nonactive participants, based on their internal capacity to conduct product assessments and manufacturing facility inspections. Currently,
there are nine member countries participating actively, namely,
Botswana, Democratic Republic of Congo, Malawi, Mozambique,
WHO Listed Authority and Other International Reliance and Harmonization Initiatives
Namibia, South Africa, Tanzania, Zambia and Zimbabwe. The
remaining member countries do not participate actively in dossier
assessment but are involved in training programs and information
sharing on products approved by the collaborative procedure. The
non-active member countries of ZaZiBoNa are Angola, Comoros
Islands, Madagascar, Seychelles and Swaziland, whilst the observer
countries are Lesotho and Mauritius. In the long term, all SADC
countries are expected to participate actively, depending on their
capacity. There is mutual agreement and consent is given by applicants for sharing information concerning the products being considered. When a product has been approved by the ZaZiBoNa initiative,
it means that the product has attained marketing authorization in
all the participating countries. Applicants who wish to participate
in the ZaZiBoNa initiative should have applied for registration of
a medicinal product in at least two of the participating countries.
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The ZaZiBoNa initiative was later absorbed by the SADC Medicines
Registration Harmonization project that was launched in 2015, and
funded by the World Bank for the period 2018–2020. In addition to
strengthening and expanding areas of technical cooperation among
member NRAs through initiatives such as ZaZiBoNa, this project
has other objectives that include:
— ensuring that at least 80% of member states have national med-
icines regulatory authorities that meet minimum standards;
— ensuring regional harmonization of medicines regulatory sys-
tems and guidelines;
— facilitating capacity building of medicines regulatory authori-
ties in member states through the implementation of quality
management systems; and
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
— developing and implementing national and regional integrated
information management systems to facilitate decision-making and sharing of knowledge among member states and stake
holders.
Various activities are ongoing currently to fulfil these objectives, for
example, most SADC countries have conducted self-benchmarking of
their regulatory systems using the WHO GBT. In addition to existing SADC guidelines, regional guidelines for variations and biosimilars are under development. An audit of regulatory assessment skills
and competencies in the region using the WHO global competence
framework for regulators is also being conducted.
4.6. Conclusion
The increasing number of global harmonization initiatives such as
ICH, ICMRA, Access Consortium, ASEAN, EAC, EMA and ZaZiBoNa is clearly a positive development. Going forward, it is hoped
that some of these harmonization initiatives will eventually evolve
into mutual recognition and reliance schemes to avoid duplication
of inspection and regulatory eorts. It is also hoped that greater
inter-collaborations take place amongst some of these global harmonization initiatives leading to a “merger” of some of these initiatives with similar and overlapping objectives, and their eventual
transformation into international reliance schemes. These mutual
recognition and reliance schemes will certainly help regulatory
authorities expedite the product approval process. Manufacturers
will also benefit from a reduction of on-site inspections which can
be duplicative in nature. In a nutshell, eective implementation of
reliance programs will benefit not only the regulatory authorities,
WHO Listed Authority and Other International Reliance and Harmonization Initiatives
but also the industry, the healthcare providers and, ultimately, the
patients and consumers.
Singapore HSA strongly supports international reliance and global
harmonization initiatives. The reliance programs that Singapore
HSA engages to facilitate pharmaceutical inspections include the:
— Singapore-Australia MRA on GMP Inspection, eective 2001;
— ASEAN Sectoral MRA on GMP Inspection, eective 2012;
— PIC/S GMP Inspection Reliance, eective 2018;
— Singapore-New Zealand MRA on GMP Inspection, eective
2020; and
— Korea-Singapore MRA on Pharmaceutical GMP Inspection,
eective 2024.
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Singapore HSA is also a member of the:
— ICMRA since 2012;
— ICH since 2017; and
— Access Consortium since 2021.
As a pioneer WLA eective 2023 which is accredited to the WHO
GBT ML4, Singapore HSA hopes to lead by example, in international reliance, harmonization and convergence of inspection and
regulatory functions.
Part II
GMP Compliance and Manufacture
of High-Quality Medicinal Products
Chapter 5
Compliance of Pharmaceutical
Manufacturers to Good Manufacturing
Practice Standards
139
5.1. Introduction to GMP
ere is a fun fact. The abbreviation GMP has been
associated with Great Mountains of Papers as well as
Guarantees Maximum Profit. These associations of
H
ral International Society for Pharmaceutical Engineering Singapore
Conference in 2001. Both the founding CEO of the newly established
Singapore Health Sciences Authority (HSA), Dr. Clarence Tan, and
the co-author, Sia Chong Hock, who was the founding Director of
GMP were mentioned tongue-in-cheek at the inaugu-
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
the GMP Audit Unit of HSA, were invited as keynote speakers to
this conference. The Business Times of Singapore picked up the two
associations for GMP which were highlighted during the conference
and reported them the following day on 26 June 2001 (see report
Compliance of Pharmaceutical Manufacturers to Good Manufacturing Practice Standards
on previous page). In its report, the Business Times quoted: The new
regulator, namely the Health Sciences Authority, will adopt high standards
but will not impede industry growth. It will be a health inspector that is
industry-friendly says its CEO, Dr. Clarence Tan. The Business Times also
quoted: His colleague, Sia Chong Hock, whose job is to ensure that the
industry adhere to GMP, was even more vivid in conveying HSA’s support
for the industry. In Singapore GMP is also known as “guarantees maximum
profit”, he said. This is in contrast to Europe where GMP is referred to as
“great mountains of papers”.
Fortunately, or unfortunately, both associations for the abbreviation (GMP) have not been forgotten, and have remained to this day.
Ocially, GMP stands for Good Manufacturing Practice(s). GMP is
a quality system standard implemented by manufacturers to assure
that medicinal products are consistently manufactured and controlled to the quality appropriate for their intended uses. The small
letter “c” is sometimes added as a prefix to GMP, i.e., cGMP. This is
used to refer to current Good Manufacturing Practice(s) to emphasize that GMP standard is not cast in stone; it is a living standard
and is dynamic. GMP standard will change in tandem with changes
in pharmaceutical science and technology, pharmaceutical laws and
regulations, the use of computerized systems and information technology as well as other developments associated with Industry 4.0.
141
5.2. Overview of the PIC/S GMP Standard
Singapore has legally adopted the GMP standard of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) when HSA became
its first Asian Participating Authority with eect from 1 January
2000. The PIC/S GMP standard is ocially referred to as the PIC/S
Guide to Good Manufacturing Practice for Medicinal Products.