EC backs away from Directive on excipient GMP
pharmafile | June 17, 2009 | News story | Manufacturing and Production | Europe, excipients
The European Commission has opted not to press ahead with developing a Directive on Good Manufacturing Practices for ‘certain’ pharmaceutical excipients considered to have a higher level of risk of safety issues.
The EC came to its conclusion at the end of a lengthy consultation process which raised concerns that the implementation costs of GMP for excipients could be greater than the potential safety benefits for patients.
GMP is a legal requirement for every component of a medicine, including the active pharmaceutical ingredient and packaging materials, but excipients are currently an exception.
Despite their image as inactive – and therefore safe – ingredients, adulterated and contaminated excipients have caused some major public health disasters in recent years. Top of the list are cases where glycerin adulterated with diethylene glycol caused dozens of deaths, most recently involving a cough syrup manufactured in Nigeria which killed 40 infants.
To address this issue Article 46(f) of Directive 2001/83/EC instructed the EC to develop a framework based on a list of certain excipients for which “conditions of GMP should be applied and which should be established in implementing legislation”.
The Commission no longer believes this is a practical approach, and has moved closer to the option preferred by industry organisations such as the European Fine Chemicals Group and European Association of Chemical Distributors (FECC), which is that GMP should be applied to excipients, identified via a risk-based selection, in line with principles laid out ICH guideline Q9 GMP Annex 20 on quality risk management.
“The results of the consultation suggest a balanced approach for requiring GMP for excipients within the concert of legal requirements on manufacturing and quality control in the legal pharmaceutical framework,” said the EC’s Directorate General for Enterprise, which has responsibility for pharmaceutical legislation, in a statement on its website available here.
This would keep the responsibility for excipient GMP with the manufacturer of the finished pharmaceutical product via “a formalised decision-making process.”
However, DG Enterprise also concedes that 2001/83/EC includes a legal mandate to draw up some form of excipient GMP, so this will have to be amended for “such a concept to be pursued further”.
The Commission’s decision also ties in with the results of an independent impact assessment report it commissioned last year from consultancy firm Europe Economics. This recommended a “no-change policy”, concluding that the risks to patients from the current situation were low.
The report explored the consequences of implementing legislation, developing guidelines based on risk-management principles, allowing industry self-regulation or maintaining the status quo.
That conclusion seemed to have taken on board fears that more stringent GMP requirements could represent a disproportionate cost burden for excipient manufacturers, particularly those whose business is largely concerned with non-pharmaceutical applications.
Related Content
EC approves combination treatment for kidney cancer
The European Commission (EC) has approved Ipsen’s Cabometyx in combination with Opdivo as a first-line …
Janssen’s esketamine nasal spray gets Europe approval for new indication
The European Commission (EC) has authorised the expanded use of Janssen’s Spravato (esketamine nasal spray), co-administered …
Xellia Pharmaceuticals becomes member of Medicines for Europe
Xellia Pharmaceuticals, a manufacturer of specialty anti-infective treatments, has become a member of Medicines for …
