A primary purpose of the ICH is to:
A.Develop mandatory worldwide regulations for drug development.
B.Require FDA registration of worldwide clinical trials.
C.Require publication of negative trial results.
D.Minimize the need for redundant research.
Answer – A. Develop mandatory worldwide regulations for drug development.”
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use or ICH has many different goals. The first goal that has been set by ICH is related to harmonization of the regulatory requirements. ICH aimed at harmonizing the regulatory requirements for safety, efficacy and the quality of different medicinal products. The harmonizing process is based on development of the technical guidelines and the requirements that are important for the product registration within the pharmaceutical sector. ICH aims at reduction or elimination of the need related to repeated testing during development of the drugs. The formation of new drugs can play an important role in ensuring that the availability of new medicines is enhanced while the safeguards related to public health can also be maintained. ICH also aim at providing appropriate levels of support towards the mutual recognition that is developed between the regulatory authorities.
The first option A has been selected as the most appropriate answer for the question as it aims at setting the standards related to ensuring safety, well-being and the rights of different trial subjects properly. The integrity and accuracy levels of the generated data is also maintained effectively based on the fulfillment of the primary purpose that has been set by ICH. The major aim of ICH is related to providing the uniform standards based on the technical requirements for the human usage of the pharmaceuticals. The regulations related to ICH are mainly developed by pharma and regulatory industry-based authorities. The ensuring of effective and safe medicines is an important responsibility of ICH. The efficient development and registration of the high-quality medicines will play an important role in ensuring that the objectives and goals of the developed guidelines can be fulfilled properly.
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