Regulatory Systems

Quality, safety, and efficacy

Proven quality, efficacy, and safety of our medicines: A must!

Based on commitment to public health, we collaborate with the World Health Organization, regulatory, and other standard-setting bodies in the development and implementation of guidelines standardizing the quality of medicines.

Quality guidelines assist the implementation of legislation for medicines, and ensure that patients receive timely quality product. To protect patient health, consistent standards for quality should be applied everywhere.

Globalization of our industry has led to increasing demands on regulatory agencies to ensure the safety and effectiveness of medicines marketed in their country. Recent experiences shared by our biopharma industry, as well as figures published by national regulatory authorities, reported an increasing number of pre-approval inspections and routine Good Manufacturing and Good Distribution Practice (GMP/GDP) inspections by domestic and foreign regulatory agencies alike.

Inspections are part of the overall quality assurance system for medicines. Inspections are essential to evaluate commercial manufacturing capability, adequacy of manufacturing and control procedures, suitability of equipment and facilities, and effectiveness of the quality management system in assuring the overall state of GMP/GDP compliance. Inspections include evaluation of authenticity, and the monitoring of the quality of medicines in legitimate distribution channels, from their manufacture to end delivery.

Inspection programs should aim to include foreign and domestic establishments with the greatest public health risk potential in case of a manufacturing and/or transportation failings. This risk-based approach and quality risk management are described in International Conference for Harmonization (ICH) guidelines which apply both to our industry and the national regulatory autorities.

For us, the best inspection approach includes cooperative arrangements among competent national regulatory authorities to enable broader inspection coverage and sharing of inspection results.

Roche-Forscher im Labor für Genom-Sequenzierung
Roche-Forscher im Labor für Genom-Sequenzierung

All medicines carry potential risks as well as benefits throughout their life cycle, from production to delivery. This is why an appropriate level of regulatory oversight through continued international cooperation can facilitate the best use of regulatory and industry resources to better control overall risks, which can ultimately benefit the patients.


countries doing foreign inspections (EU = 1)

Up to 9

inspections per site per year

> 100’000 h

invested by national regulatory authorities in foreign inspection/year

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