The innovative pharmaceutical industry adheres to strict scientific and regulatory standards that enable high quality, safe, and effective medicines.

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    Overview

    IFPMA collaborates with the World Health Organization (WHO), regulatory, and other standard-setting bodies to share experience and scientific input and implement guidelines standardizing the quality of medicines and vaccines.

    The priority areas of focus for IFPMA and our members are good manufacturing practices, quality testing, post-approval changes, and clinical trials.

    IFPMA encourages processes to strengthen the overall regulatory system, optimize regulatory oversight by NRAs, avoid duplication and redundancy, and contribute to facilitating reliable global supply chains

    IFPMA

    Position Paper on Convergence of Good Manufacturing Practice (GMP) Standards and Related Inspections

    Upholding and supporting good manufacturing practices

    IFPMA and our members make sure the highest possible standards of quality, safety, and efficacy are adhered to through good manufacturing practices.

    Because of globalization, increasing demands have been made of national regulatory authorities (NRAs) 

    This includes an increasing number of pre-approval inspections and routine Good Manufacturing and Good Distribution Practice (GMP/SDP) inspections by domestic and foreign NRAs. 

    The importance of inspections

    Inspections are part of the overall quality assurance system for medicines. They’re essential to appraise commercial manufacturing capability, manufacturing and control procedures, equipment and facilities, and the quality management system.

    Inspections include evaluating authenticity and monitoring the quality of medicines in legitimate distribution channels, from manufacture to end delivery.

    >40

    countries doing foreign inspections (EU = 1)

    Up to 9

    inspections per site per year

    > 100,000h

    invested by national regulatory authorities in foreign inspection/year

    Ideally, inspection programs should include foreign and domestic establishments with the greatest public health risk potential in case of a manufacturing and/or transportation failings.

    To enable broader inspection coverage and sharing of inspection results, the best inspection approach includes cooperative arrangements between competent NRAs.

    As technology advances, the use of digital tools will become more prevalent in all regulatory processes. IFPMA’s position paper on virtual inspections reflects the importance of leveraging such tools through an efficient and risk-based approach.

    Inspections and national regulatory authorities

    Because of globalization, increasing demands have been made of national regulatory authorities (NRAs). This includes an increasing number of pre-approval inspections and routine Good Manufacturing and Good Distribution Practice (GMP/SDP) inspections by domestic and foreign NRAs.

    The Pharmaceutical Inspection Co-operation Scheme

    IFPMA supports the NRAs’ efforts on convergence – in this case, aligning regulatory requirements over time. This includes leveraging tools available from the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and implementing its guidance.

    Over the past 50 years, PIC/S has played a central role in facilitating collaboration between countries in GMP inspections. It continues to be a leading platform for countries to jointly address issues related to collaboration in inspection activities and how to adapt to the ever-changing manufacturing environment.

    NRAs that become members of PIC/S should find it easier to communicate more openly, exchange information, and benefit from training. PIC/S membership will also help them agree on mutual recognition agreements where appropriate.

    Convergence on GMP/GDP standards and related inspection processes is also important to achieve a reliable global supply of quality medicines.

    In its position paper on the Convergence of GMPs and inspections, IFPMA encourages NRAs to leverage PIC/S available tools and to implement its guidance, whether they are members or not.

    Quality testing

    Quality control is an important element of a country’s regulatory oversight. IFPMA encourages a risk-based approach to in-country quality testing, focused on post-marketing surveillance testing.

    This ensures quality without delays in supply and offers the potential to reproduce control tests and detect falsified and substandard medicines in local distribution channels.

    Study results demonstrate that import testing does not add benefit to the quality or safety of drugs, provided that the products are continuously controlled according to Good Manufacturing Practices (GMPs) and Good Distribution Practices (GDPs).

    IFPMA recommends more collaboration between NRAs and implementation of reliance on testing from networks of regional control testing laboratories to eliminate redundant import testing and speed up supply to patients.

    Physical samples

    Using physical product samples for quality control testing should be minimized as much as possible, specifically for highly innovative and complex products, to maximize supply availability for use in patients.

    Redundant testing puts further strain on NRAs and industry, both when it’s done for the approval of new products or to approve variations to registered products packaging or manufacturing processes.

    More information on this topic, including IFPMA recommendations on import testing, in-country testing, and in-country testing for ATMPs, is available in different languages.

    Post-approval changes

    Post-approval changes (PACs) to the registered information of authorized products are routinely introduced globally to help enable a robust, efficient manufacturing process.

    They also help make sure supply remains timely, improve quality control techniques, and enable manufacturers to react to changes in regulatory requirements and upgrade to state-of-the-art facilities.

    PACs can be difficult to implement because of the globalization of supply chains and NRAs occasionally applying requirements and review timelines unpredictably.

    IFPMA and PACs

    IFPMA believes that global regulatory convergence, such as work sharing between NRAs, as well as reliance-based processes, will provide a more efficient and predictable environment for the management of PACs worldwide.

    Global regulatory convergence will also contribute to making sure patients have continued access to quality medicines and up-to-date product safety information.

    IFPMA proposes the implementation of a tiered, risk-based classification system for variations based on the principles outlined by the WHO.

    Case studies

    IFPMA has put together a series of case studies that describe the extensive process some of our member companies had to go through to have innovative PACs implemented.

    Clinical trials

    IFPMA member companies conduct high quality, science-driven studies to develop innovative medicines for patients in need and vaccines for use in healthy populations.

    Studies are carried out according to international regulatory and ethical standards such as the Declaration of Helsinki and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. Companies also carry out research in compliance with national regulations and ethical requirements.

    Our members are fully committed to enhancing public health by sharing clinical data responsibly and making clinical trial results available.

    Companies provide access to trial results data for the benefit of public health. For example, biopharmaceutical companies routinely collaborate with academic researchers, publish their clinical research in peer-reviewed literature, and share clinical trial information including results on public websites.

    Public platforms for clinical trials information are the WHO International Clinical Trials Registry Platform, US NIH ClinicalTrials.gov database, Health Canada Clinical Information Portal, EU Clinical Trials Register, EMA’s Clinical Data Website, and Japan Registry of Clinical Trials.

    Appropriate data sharing supports:

    Patients

    Making sure the privacy of patients, clinical investigators, and trial participants is safeguarded

    National regulatory systems

    Respecting the integrity of national regulatory systems

    Biomedical research

    Maintaining incentives for investment in biomedical research

    Our pledge

    IFPMA, the European Federation of Pharmaceutical Industries and Associations (EFPIA), Japanese Pharmaceutical Manufacturers Association (JPMA), Pharmacy Research and Manufacturers of America (PhRMA), and their member companies have pledged to registering all clinical trials conducted with patients on a public registry. We are also committed to disclosing the results of industry-sponsored clinical trials with patients through public databases.

    Position paper 21 November 2022

    Clinical research in resource-limited settings

    Read our perspective, which includes examples and case studies of how members contribute their expertise and knowledge to expand the clinical research infrastructure in LMICs.

    Read more
    Position paper 21 November 2022

    Diversity and Inclusion in Clinical Trials: Bioethical Perspective and Principles

    As IFPMA members, we believe that the knowledge gained from clinical trials should be used to support the development and use of innovative medicines, vaccines and other therapies, in order to develop the right treatment for the right patient.

    Read more

    Diversity and low- to middle-income countries

    The pharmaceutical industry is taking affirmative steps to increase clinical trials diversity. This is a matter of equity and scientific rigor.

    We are also committed to helping expand the clinical research infrastructure in LMICs to drive advancement of healthcare systems and address the needs of populations.

    Evolving clinical research

    IFPMA members conduct high quality, science-driven studies to develop innovative medicines and vaccines for unmet patient needs. Discover how they contribute to the evolving clinical research ecosystem.

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