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. 

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.

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.

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 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).

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 (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 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.

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.

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.