Sentence examples for requirement for harmonisation from inspiring English sources
Following intervention by the EMA in January 2009 and the requirement for harmonisation of product information within the SPCs of products containing methylphenidate, the contraindications given within the SPCs for these medications are now almost the same.
Since the inception of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in 1990, harmonization of regulatory requirements has been progressively and successfully achieved in major jurisdictions around the world.
International council for harmonisation of technical requirements for pharmaceuticals for human use.
Thus, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), as well as the United States Pharmacopeial Forum discuss the enrollment of new guidelines that include life cycle management of analytical methods.
Thus, the US Food and Drug Administration FDAandand the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) issued Guidance for Industry Q1B "Photostability Testing of New Drug Substances and Products" for testing of pure but also packed drugs.
All clinical work was conducted in compliance with Good Clinical Practices and Good Laboratory Practices as referenced in the International Conference for Harmonisation guidelines (ICH E6), local regulatory requirements, and the recommendations laid down in the Declaration of Helsinki (World Medical Association 2013).
The current International Commission for Harmonisation (ICH) regulations regarding stability testing requirements for a Registration Application provide the stress testing conditions with the aim of assessing the effect of severe conditions on the drug product.
Irish officials have reacted angrily, calling the scheme "just harmonisation for harmonisation's sake".
The EU is trying to push for harmonisation but the systems are still very, very different".
International conference for harmonisation guidelines.
The EURADOS (European Radiation Dosimetry Group) working group (WG2) on Harmonisation of Individual Monitoring in Europe has shown that intercomparisons are fundamental for harmonisation of individual monitoring.
