4 DRUG DISCOVERY AND DEVELOPMENT


Is the global harmonisation of regulations for medicines just around the corner?


Ken Appel summarises recent reforms and new co-operative initiatives to move to worldwide standards that have potential impact for pharmaceutical and life sciences industries.


Ken Appel récapitule les récentes réformes et les nouvelles initiatives de coopération visant à passer à des normes mondiales ayant un impact potentiel pour les secteurs pharmaceutique et des sciences de la vie.


Ken Appel fasst die jüngsten Reformen und neuen Initiativen zur Zusammenarbeit in Richtung weltweiter Normen, die die Pharma- und Life Science- Branchen potentiell beeinflussen könnten, zusammen.


Right The days of different interpretations of the same rule are fading away.


S


hifting economies and pharmaceutical mergers are driving legislation by the


major regulatory regions of the world — EU, US, Australia, New Zealand, Switzerland and Japan — to be more vigilant in protecting the health of its citizens.


In the past few years, the movement has accelerated in medicine research and manufacturing organisations as seen by enforcement actions of the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the agencies of countries mentioned above.


Expansion of the industry geographically to reduce costs and the number of drugs under development are occurring at a much faster rate than agencies’ ability to


inspect laboratories, manufacturing and distribution facilities.


In North America, both Canadian and US regulatory agencies have accelerated regulatory enforcement to protect patient safety and revamp auditing methodologies for best utilisation of regulatory resources.


Now, global regulatory bodies and standards organisations such as the World Health Organisation (WHO) and International Committee on Harmonisation (ICH) are drawing upon common language to harmonise guidelines worldwide.


Inside Europe In September 2010, the European Parliament committed to adopt new pharmacovigilance legislation, expected to come into force by 2012. Te proposed directive and


regulation is designed to strengthen the methods for monitoring the safety of medicines for human use in the EU. proposed “changes include enhanced monitoring of the benefits and risks of medicines post- authorisation, replacement of the pharmacovigilance working party with a committee, and an increased level of transparency of safety information.”


In Nov 2009, the UK Medicines and Healthcare products Regulatory Agency (MHRA) scoped out its strategy for good distribution practice (GDP) risk assessments.


Once an audit has taken place, the frequency of future inspections will be determined by the agency’s risk ranking.


Te top three GDP ranking deficiencies between January and June 2010 were temperature control and monitoring for cold and general storage, lack of or inadequate written procedures, and facility equipment and calibration.


Again, the common theme is a move towards using agency resources to isolate high risk areas for inspections.


Europe and North America Also in September 2010, the EMA and FDA extended their confidentiality arrangements related to medicinal products for human and veterinary use. It allows both agencies to exchange confidential information as part of their regulatory and scientific processes.


Information exchange will cover scientific advice, orphan drug designation, pediatric development, GMP and GCP inspection planning


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