Sentence examples for harmonization of technical requirements from inspiring English sources

Various guidelines harmonized in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) (e.g., Good Manufacturing Practice guide for Active Pharmaceutical Ingredients) and originally prepared for new drug products, also play important roles in the production of high quality generic drug products.

Miller, Michelle D. (1997) "The Informed-Consent Policy of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use: Knowledge is the Best Medicine, Cornell International Law Journall: Vol. 30 : No. 1, Article 5.

The International Council on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use [1994. Guidelines for industry: Dose-response information to support drug registration. ICH-E4.

Regulatory guidance regarding JAS is available from The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M3 R2) guideline and from more specific guidance documents issued by the Food and Drug Administration FDAas as well as the European Medicines Agency EMAA).

International Conference on Harmonization of technical requirements for pharmaceuticals for human use.

The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use E14 guideline recommends a dedicated study to evaluate drug-induced effects on cardiac repolarization ("thorough QT/QTc study").

The proposed SIC method was validated under the optimized conditions according to the guidelines of the main regulatory agencies, namely International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use [25] and the International Union of Pure and Applied Chemistry IUPACC) [26].

The design, implementation, and reporting of the VISION study are strictly in compliance with the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline for Good Clinical Practice (GCP), and the Helsinki Declaration of ethical principles [ 39, 40].

Indeed, the guidelines from the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use (EMEA 1998) explicitly state that such analyses should be used in an exploratory manner only and that conclusions as to the efficacy of a treatment should not be based on such analyses alone (Boonen et al 2005).

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.

As the degree of regulatory cooperation advances from sharing of submitted data to work sharing/mutual reliance on other authorities' work, and to decision sharing/mutual reliance on other authorities' decision, the necessary level of harmonization also advances from that of technical requirements to regulatory practice and to decision criteria.