Falsified active substances and active substances that do not comply with applicable requirements of Directive 2001/83/EC pose serious risks to public health.
In recent blog posts I have pointed out certain new developments arising because of the Falsified Medicines Directive (FMD) that affect the control of API’s. Today I want to write about excipients!
Excipients and there are more than a thousand used in EU medicines are also subject to the new FMD legislation. For instance the Directive states:
“There is a range of different good manufacturing practices that are suitable for being applied to the manufacturing of excipients. In order to provide for a high level of protection of public health, the manufacturer of the medicinal product should assess the suitability of excipients on the basis of appropriate good manufacturing practices for excipients.”
This requirement will be achieved by formalised risk assessments to judge if each excipient is suitable for its intended purpose [refer to Articles 46(f) and 47 (fifth paragraph) of the FMD].
To increase your understanding of the regulatory and compliance issues affecting Substances for Pharmaceutical Use please book to reserve your place at our upcoming (2-3 July 2013) CTD Module 3 course in London. Bookings close very soon!
From Expert Speakers, a RARE BLEND OF REGULATORY INSIGHT on Biologicals/ Biotechnologicals/ Biopharmaceuticals is available in a few weeks’ time in Stratford-upon-Avon, UK.
The Course Leaders have years of experience as Assessors or Advisers to European Authorities and aim to guide you to a much better understanding of what is expected in Regulatory Applications for these important pharmaceutical products.
To learn more about and to book a place on the Course “Regulatory Training and Biological/Biotechnological Drug Substances and Products” ” to be held on 22-23 June 2010 visit the web site
As a delegates manual, accommodation and meals including a course dinner are part of the training packages at £995 + 17.5% VAT your only additional expenses could be your travelling costs.
Biopharmaceuticals are a major and growing focus of the pharmaceutical industry’s activities with global annual sales of prescription biotechnologicals in excess of $90 billion.
Manufacturing procedures may involve extraction of biological substances from microbial cells or human and animal tissues such as blood, or natural, hybridised or otherwise-modified tissue cells. Not surprisingly, biological active ingredients are usually very expensive to produce, especially if recombinant-cell technology is used.
Do you manage staff that need training in scientific subjects of particular importance from a regulatory perspective, so that their business contributions help to make your Clinical Trial and Marketing Authorisation Applications successful?
At our Biologicals Course on 22-23 June 2010 in Stratford-upon-Avon, UK, my colleagues and I will help your staff acquire useful regulatory knowledge and scientific writing skills about biopharmaceuticals.
Are you developing or thinking of developing a regulatory or allied career in the biopharmaceuticals area?
Do you know what makes a biological/biotechnological product different from non-biological (conventional) ones? From a licensing perspective, just why and how are biologicals and biological medicines treated differently from non-biologicals?
There are many official guidelines to help you both to interpret the meaning of the law when developing a biological medicine and to compile acceptable IMP and MA dossier applications. At our Biologicals Course on 22-23 June 2010 in Stratford-upon-Avon, UK, my colleagues and I will help you in these tasks.