Drug Registration Guidance 2073. (Issued under Drug Registration Regulation 2038). MOH, Nepal, 2016
(2016; 177 pages)


Medicines registration is the process by which a national regulatory authority approves the use of a medicine in a country, having considered evidence of the Medicine’s safety, quality and efficacy. It is thus primarily concerned with protecting public health. Product assessment and registration are carried out by the drug regulatory authority to ensure that the pharmaceutical products meet appropriate standards of safety, efficacy and quality. There are different divisions under Department of Drug Administration (DDA) namely Registration, Management and Inspection division. Under each division there are different sections. These sections are responsible to carry out the regular regulatory and administrative function under DDA. The development of the guideline was felt need towards better management of regulatory system. The present registration guidance document encompasses the drug registration requirements and processes applicable to all kinds of medicines manufacturing and marketing authorization, importation recommendation and different permission, pharmacy registration. The guidance document is also expected to promote accountability and transparency of the regulatory processes and facilitate communication between the regulatory authority, the pharmaceutical industries, importers, media, health care stakeholders, and the public. Compliance to this guideline will facilitate the speedy processing and evaluation of the applications and subsequent registration of the medical products and help to promote good regulatory practice leading to better governance of the sector.

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