ICH survey shows greater regulatory harmonisation among pharmaceutical companies and regulators

The results of a recent survey released by the International Council on Harmonisation (ICH) suggest that pharmaceutical companies and regulators around the world are adopting and adhering to its guidelines on quality, safety and efficacy in drug development.

The mission of the ICH has been to promote public health by achieving greater regulatory harmonisation, through the development of technical guidelines and requirements for pharmaceutical product registration.

In the latest survey, 32 pharmaceutical companies provided responses on 15 regulatory authorities including the European Medicines Agency (EMA), the United States (US) Food and Drug Administration (FDA), Health Canada, Swissmedic and the Pharmaceutical and Medical Devices Agency of Japan (PMDA).

Guidelines relating to stability (Q1), good manufacturing practice (Q7) and good clinical practice (E6, R2) were implemented consistently by all regulators. Generally, most other guidelines were implemented without modification, but the proportion of modifications were highest for Malaysia, Russia, South Africa and Turkey. All of the modifying countries felt that their modifications provided clarity and facilitated implementation by their industries, without increasing regulatory requirements.

Some companies however, felt that their perceptions of the guidelines on clinical safety data (E2B), and the electronic common technical document (M8), varied slightly from their respective agencies.

Overall, all regulators said they felt that they were adhering to the guidelines and applying them adequately in day-to-day practice.

To view the full survey report, click here.