Tag Archives: Pharmaceutical

regulatory intelligence

Our Current Objectives

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.

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What is a biosimilar product?

There are different legal and scientific requirements for Marketing Authorisation (MA) application dossiers for ‘small molecule’ generics as distinct from ‘biosimilars’; the latter being sometimes known as ‘biogenerics’ or ‘similar biological medicinal products’.

At our Biologicals Course on 22-23 June 2010 in Stratford-upon-Avon, UK, my colleagues and I will help you understand the regulatory meaning and impact of comparability.  In doing this we will examine relevant EU legislation and guidelines and will discuss the quality and safety requirements that have to be met in order to market efficacious products popularly known as ‘biosimilars’.

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Do you understand the meaning of comparability when linked to the world of biopharmaceuticals?

Although huge challenges face the innovators of conventional, sometimes called small molecule’, drugs that are usually synthetic or semi-synthetic organic compounds, they may be even greater for the ‘biological’ innovator.  Understanding the regulatory demands on these different products is critical to success in pharmaceutical research & development.

For biological materials and products, there is enormous diversity in the types of manufacturing process used and in the nature of the starting materials, which is not surprising when you consider examples of product types such as recombinant proteins, hormones, growth and coagulation factors, monoclonal antibodies, vaccines.

Genetic engineering as well as cell- and tissue-culture technologies is often involved and raises further complex issues.

There is a regulatory expression ‘comparability’ and it might become a key subject in your Marketing Authorisation (MA) applications.  It can be very costly and time-consuming to demonstrate.

At our Biologicals Course on 22-23 June 2010 in Stratford-upon-Avon, UK, my colleagues and I will help you understand the regulatory meaning and impact of comparability.  In doing this we will examine relevant EU legislation and guidelines and will discuss numerous, associated pharmaceutical (CMC) and non-clinical (toxicological and immunological) subjects.

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