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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
This will facilitate the global development and registration of pharmaceutical products, reducing duplication of eorts and improving
access to safe and eective medicines.
• Collaboration with Stakeholders
ICH recognizes the importance of engaging with various stakeholders, including patient organizations, healthcare professionals, and
academia. Collaboration with these stakeholders will help ensure
that the guidelines developed by ICH address their needs and
concerns.
• Focus on Quality Management Systems
ICH will continue to emphasize the importance of quality management systems throughout the lifecycle of pharmaceutical products.
This includes aspects such as risk management, quality control, and
post-approval changes.
Overall, the future direction of ICH involves expanding membership, modernizing guidelines, enhancing regulatory convergence,
collaborating with stakeholders, and emphasizing quality management systems. These eorts aim to promote global harmonization
and facilitate the development and availability of safe and eective
pharmaceutical products worldwide.
4. 5.7. International Coalition of Medicines Regulatory
Authorities (ICMR A)
4.5.7.1. Introduction
The proposal to create ICMRA is anchored in the recognition that
a Heads of Agency leadership is needed to address current and
WHO Listed Authority and Other International Reliance and Harmonization Initiatives
emerging human medicine regulatory and safety challenges
globally, strategically and in an
ongoing, transparent, authoritative, and institutional manner. In May 2012, more than 30 NRAs participated in a seminar
in Geneva that was promoted by Brazil. This seminar was aimed
at stimulating a debate among health ocials and the diplomatic
community on how to improve cooperation among NRAs. The
discussion highlighted the importance of better promotion and
coordination of international cooperation among medicines regulatory authorities. The topics discussed included strengthening
dialogue, facilitating wider exchange of reliable and comparable information, encouraging greater leverage of resources and
work products of other NRAs, and promoting better informed
risk-based allocation of limited resources of NRAs. These eorts
would strengthen the quality, safety and ecacy of medicinal
products globally.
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4 .5 .7. 2. Addressing Common Regulatory Issues
The above-mentioned discussions were further pursued at meetings
of senior executives of several NRAs held on the margins of ICDRA
in October 2012, as well as at the 7th Heads of Medicines Regulatory
Agencies Summit in December 2012. Following these meetings,
a consensus emerged on the desirability of developing ICMRA to
address common regulatory issues, such as the following areas:
• Growing complexity in manufacturing and distribution supply
chains for the medicinal product which are multi-faceted and
globally integrated;
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
• Ability of NRAs to ensure the safety, quality and ecacy of
medicinal products which requires knowledge of and confidence in these supply chains;
• Gaps in global regulatory oversight providing opportunities for
the tampering and counterfeiting of medicinal products;
• Growing complexity in medicinal products and their ingredi-
ents (e.g., new chemical entities and innovative drugs) posing
new scientific and regulatory challenges which call for new regulatory processes;
• Growing number of international regulatory initiatives, lacking
in integration and strategic oversight;
• Continued pressures to control and reduce regulatory public
expenditures; and
• Continued industry and political pressures to harmonize and
align regulatory practices and activities.
Overall, ICMRA hopes to provide a global architecture to support
enhanced communication, information sharing, crisis response and
address regulatory science issues.
4.5.7.3. ICMRA Pilot Program for Collaborative Hybrid Inspection
Following a July 2021 ICMRA-Industry Workshop on enabling
manufacturing capacity in the COVID-19 pandemic, ICMRA recognizes the need to assess the feasibility of a collaborative hybrid
inspection to better understand the challenges and benefits of this
new approach to both the regulators and industry. Soon after, an
ICMRA Pilot Program for Collaborative Hybrid Inspection was initiated. A protocol (implementation plan) for carrying out this pilot
program had been published by ICMRA. Appended is a summary of
some of the key points of this protocol.
WHO Listed Authority and Other International Reliance and Harmonization Initiatives
• Scope
The scope of the pilot will be limited to pre-approval and pre-license
drug inspections and will not include surveillance drug inspections.
The scope of the collaborative hybrid inspection should be well
defined and aligned with the legal requirements and standards of
the participating NRAs. The pilot also aims to evaluate operational
eciency and cost ecacy; however, due to the limited sample size
it is anticipated that further evaluation will be needed to determine
the full impact of this new approach on regulatory authorities’
operations and costs. English will be the designated language of the
program.
• Objective
The objective of the pilot is for multiple regulatory authorities to
engage in an interactive, collaborative assessment while inspecting
a manufacturing facility using a combination of on-site inspection
and remote assessment of a manufacturing facility. The Collaborative Hybrid Inspection Pilot aspires to conduct three to five inspections to support the scope and objectives. The ICMRA pilot for
collaborative hybrid inspection will guide regulatory authorities to
gain information on how to prepare, execute and report a collaborative hybrid inspection and describes how participating stakeholders,
namely the NRAs and the industry, can engage to allow evaluation
of a facility via a collaborative hybrid inspection approach. With the
planned sample size of three to five inspections, the goal of the pilot
is to understand how the collaborative hybrid process may work,
gain an initial understanding of costs and benefits this additional
alternative approach presents to all involved, and determine next
steps to assess feasibility for implementation on a larger scale. The
lessons and information collected from this eort will need to be
evaluated by each regulatory authority to determine how it aligns
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
with their inspection program. This is not meant to change each
regulatory authority’s inspection process.
• Benefits
The anticipated benefits for a participating pharmaceutical manufacturing facility are the assessment of the facility (in terms of
inspectional requirements) by multiple NRAs simultaneously in
one single engagement. This is expected to save the time, eort, and
resources for the manufacturing facility which is being inspected.
The collaborative hybrid inspection will also allow multiple NRAs
to take action and thus potentially accelerate the availability of critical medicines in multiple markets.
• Implementation Plan
In order to ensure feasibility of this ICMRA pilot program for collaborative hybrid inspection, a small number of regulatory authorities (about three to five NRAs, with some regulatory authorities
participating as an observing inspectorate) will participate in such
collaborative hybrid inspections. As more experience is gained, the
pilot may be extended to additional NRAs. Even though initial participation is limited, requests for participation from other NRAs
during the pilot may be received and discussed by participants. The
minimum active participation will be two NRAs (one on-site and
one remote).
• Information Technology (IT) Tools
IT tools used for the collaborative hybrid inspection have to be
agreed upfront among all parties, including the inspectorates and
manufacturing facility. All parties have to ensure that privacy, security and confidentiality are preserved. Before the inspection the IT
platforms and connection should also be tested in advance. Signal
WHO Listed Authority and Other International Reliance and Harmonization Initiatives
strength and bandwidth capacity should be high enough to allow
a stable and fast connection. Broadband should be available in all
areas especially where the inspectorates will carry out the virtual
plant tour that may need video streaming. This is because the livestreamed video quality of the tour can be aected by the limitations
of the reach of the Wi-Fi signal within the manufacturing facility.
To minimize disruption, the inspected company should provide IT
professionals in the preparation as well as during the inspection to
support all technology-related aspects.
A detailed Implementation Plan for the ICMRA Pilot Program for
Collaborative Hybrid Inspection is available at the ocial ICMRA
website at https://icmra.info/drupal/en.
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4.5.8. International Pharmaceutical Regulators Program (IPR P)
The Regulators Forum was
originally created in 2008
as an informal platform for
discussing and promoting
harmonization activities amongst NRAs and regional harmonization initiatives. Over time, the Regulators Forum evolved to
a point where it needed a more formal structure. This resulted
in the creation of the International Pharmaceutical Regulators
Forum (IPRF) in 2013. Back then, the IPRF and another initiative, namely, the International Generic Drug Regulators Program
(IGDRP) had complementary objectives and a largely overlapping
membership, albeit dealing with dierent product scopes. IPRF
focused on innovative pharmaceutical products, whilst IGDRP
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
focused on regulatory issues specific to generic pharmaceutical
products. Recognizing the potential gain in eciencies and creation of synergies, IPRF and IGDRP agreed to a consolidation of
the two initiatives. In January 2018, the IPRF and IGDRP were
brought together under one roof, and they now function under
the merged entity called the IPRP. Today, membership of IPRP
includes many national and regional regulatory authorities from
around the world, with the WHO and the European Directorate
on the Quality of Medicines and Healthcare as observers. IPRP
represents an international platform for its regulatory members
and observers with the following goals:
• Sharing of best practices and regulatory experience;
• Discussion of topics that are of mutual interest, especially new
scientific technologies and regulatory challenges;
• Promotion of a consistent implementation of ICH guidelines;
and
• Promotion of a possible approximation of regulatory
requirements.
Currently, the IPRP comprises eight Working Groups as follows:
— Quality Working Group for Generics
— Bioequivalence Working Group for Generics
— Information Sharing Working Group for Generics
— Biosimilars Working Group
— Nanomedicines Working Group
— Gene therapy Working Group
— Cell therapy Working Group
— Identification of Medicinal Products Working Group.
WHO Listed Authority and Other International Reliance and Harmonization Initiatives
4.5.9. Latin America
At present, there are no strict regulatory harmonization among
Latin American countries on regulatory reliance and recognition under one roof. Nonetheless, eorts are being made towards
greater harmonization to leverage the work done by Latin American countries to minimize duplication of work. In particular,
there are initiatives to converge national regulations through the
adoption of internationally accepted guidelines such as those of
the ICH with the view to expedite the product approval process.
Latin American countries are also working to reinforce harmonization through the Pan American Health Organization by sharing
information and developing common pharmacopoeia. Similarly,
discussions are taking place in the Latin American region to rely
entirely or partly on approval decisions made by the EMA and the
US FDA. Latin American countries such as Argentina, Colombia,
Mexico and Peru are now accepting GMP certificates issued by
EMA and US FDA. However, Brazil ANVISA still carries out its
own inspections.
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In addition to the above initiatives on reliance and harmonization,
some of the inspectorates of Latin American countries are joining
forces with international inspection authorities. In 2016, Brazil
became the first Latin American country to be a member of ICH
whilst Cuba, Mexico and Colombia became observers. In January
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
2018, Argentina National Institute of Drugs became the 1st PIC/S
Participating Authority from Latin America. This was followed
by Mexico and Brazil. Over the years, many international developments in pharmaceutical inspection, regulatory harmonization
and reliance have come out from Latin America. Beyond the above
initiatives, Argentina, Brazil, Colombia and Cuba are entering into
cooperation agreements related to inspections and market recalls
sharing information to avoid duplication of work and expedite market access. Another example of regulatory harmonization was the
signing of an agreement in 2016 between Brazil ANVISA and the
United States Pharmacopoeia to cooperate on harmonizing pharmacopoeia to minimize duplication of work.
4.5.10. Pharmaceutical Inspection Co-operation Scheme (PIC/S)
4.5.10.1. Introduction
The PIC/S was established in 1995 as an extension to the Pharmaceutical Inspection Convention (PIC) of 1970. PIC/S is a non-binding
and informal co-operative arrangement
amongst its Participating Authorities in
the field of GMP of medicinal products for
human or veterinary use. It is open to any medicines NRA having
a comparable GMP inspection system. The goal of PIC/S is to lead
the international development, implementation and maintenance of
harmonized GMP standards (for the pharmaceutical manufacturing
industry) and quality systems (for Inspectorates) in the field of medicinal products. The PIC/S secretariat is based in Geneva, Switzerland
and the PICS website can be accessed via http://www.picscheme.org/.
The PIC/S GMP standard is studied in depth in Chapter 5.
WHO Listed Authority and Other International Reliance and Harmonization Initiatives
4.5.10.2. PIC/S Participating Authorities
As at 1 January 2024, PIC/S comprises 56 Participating Authorities
coming from dierent parts of the world (Europe, Africa, America,
Asia and Australasia). PIC/S aims at harmonizing inspection procedures worldwide by developing common standards in the field of
GMP and by providing training opportunities to inspectors. It also
aims at facilitating cooperation and networking between competent authorities, and regional and international organizations, thus
increasing mutual confidence. This is reflected in PIC/S’ mission
which is to lead the international development, implementation
and maintenance of harmonized GMP standards and quality systems of inspectorates in the field of medicinal products. This is to
be achieved by developing and promoting harmonized GMP standards and guidance documents, training competent authorities, in
particular inspectors, assessing (and reassessing) inspectorates and
facilitating the cooperation and networking for competent authorities and international organizations. PIC/S comprises the following
Participating Authorities:
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1. Argentina National Institute of Drugs
2. Australia Therapeutic Goods Administration
3. Austria Federal Oce for Safety in Health Care
4. Belgium Federal Agency for Medicines and Health Products
5. Brazil National Health Surveillance Agency
6. Bulgarian Drug Agency
7. Health Canada
8. Taiwan Food and Drug Administration
9. Agency for Medicinal Products and Medical Devices of
Croatia
10. Cyprus Pharmaceutical Services