Good regulatory practice and individual professional codes require staff working in pharmaceutical regulatory affairs to be trained appropriately and to maintain their professional competences [Continuing Professional Development (CPD)].
Through our regulatory consultancy and training businesses Pharmaceutical Quality Matters and PharmaQMtraining.eu, we can provide regulatory expertise and training on pharmaceutical subjects concerning drug substances (active substances) from their discovery onwards until they become drug products (finished medicinal products/dosage forms). If an active substance is new the regulatory demands can be huge whereas if it is a known or ‘existing’ drug substance the regulatory burden will usually be much lighter unless a new method of administration or a novel formulation is involved.
Complex regulatory procedures have to be followed and satisfied before a clinical trial can begin and there are even more extensive requirements to be met in order to gain approval of an application for a Marketing Authorisation (MA) (also known as a Product Licence, particularly in the UK) to allow a specified product to be sold or supplied to patients.
In all cases the industrial Intention of medicines’ development is to produce a safe and effective product but the story does not end with the granting of a MA. Adverse events have to be monitored, this being part of the major effort put into the regulatory topic of Pharmacovigilance.
For each particular approved medicine there is also the need for life-cycle management to keep any given product up to the required quality, safety and efficacy standards whilst recognising that commercial considerations and maintenance of supply may also be key factors.
In this site’s Blog Posts and also through the LinkedIn group Pharmaceutical Regulatory Training we will try to focus our writings on regulatory intelligence impacting on medicines’ development with a focus on new legislation and new guidelines and other relevant guidance from ICH and various national/multinational bodies in order to see how and where these may have an impact on the licensing and life-cycle management of new medicines. Contributions and analytical comments from readers will be welcomed especially where they enhance the training potential offered by these activities.