Pharmaceutical Regulatory Affairs Cover Letter

The Marketing Authorisation Holder can then legally begin to market the medicine in all EEA (European Economic Area) countries (EU EFTA States (Iceland, Liechtenstein, and Norway).

National Competent’ Authorities (NCAs) are responsible for evaluation of marketing authorisation applications and granting MAs for medicines that fall outside the scope of the centralised procedure.

A system of marketing authorisation was put in place to protect public health.

Marketing authorisations are granted only when a competent authority (or ‘regulatory authority’) has conducted a scientific evaluation, and is satisfied that a medicine is sufficiently safe and effective, and of high enough quality. The EMA (the ‘Agency’) is responsible for the ‘centralised procedure’.

It brings together the regulatory authorities and the pharmaceutical industry from five regions (Europe, Japan, USA, Canada and Switzerland).

ICH has been established in order to reduce the duplication of clinical trials and create a more streamlined regulatory assessment process for new applications.Previously, the terms clinical study and clinical trial were used synonymously. In order to market a medicine, a submission (an application) must be made to the relevant regulatory authority, for example the European Medicines Agency (EMA).Submissions provide comprehensive information about the medicine, its formulation, the trials it has undergone, its intended use, and its risks and benefits.submission of the dossier for the Marketing Authorisation Application (MAA), and other activities after the MA is granted, for instance applying for a change to the marketing authorisation (a variation).Regulatory Affairs (RA) departments are (or should be) an integral part of all steps throughout the life-cycle of the medicinal product.Regulatory Affairs are responsible in particular for the applications that must be submitted before every Clinical trial A clinical trial is a clinical study in which participants are assigned according to a pre-defined therapeutic strategy or plan (protocol) to receive a health-related intervention, such as a medicine, in order to investigate its effects on health outcomes, usually compared to another (or sometimes no) treatment.Figure 1 illustrates the development process for a new, innovative medicine.This kind of medicine would require a full dossier to be submitted, in which all elements of documentation for the medicine must be included.International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).The CTD is to be used for all types of MAAs in the EU irrespective of the procedure (Centralised procedure [CP]The centralised procedure is a process for obtaining marketing authorisation for a medicine in the EU.Clinical trials are used to evaluate clinical practices that do not fall within the current practices of a country, or to evaluate a new medicine (investigational medicinal product).Clinical trials are used to generate data on the safety and efficacy of the intervention.


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