API – the new approach for third countries – what …
API ? the new approach for third countries ? what are the consequences ? should we expect shortage of medicinal products in
the country? Perspectives from an acceding country
EU28: SCIENCE MEDICINES HEALTH, A REGULATORY SYSTEM FIT FOR THE FUTURE
Dubrovnik, Croatia, 6-7 May 2013
Mr Stefano Soro, Head of Unit Medicinal products: quality, safety and efficacy Directorate General for Health and Consumers
Health and Consumers
The European Union (EU) Directive 2011/62/EU - main contents
Obligatory safety
features
Actors in the supply chain
Active substances,
quality
,Online pharmacies`
2
Structure of talk API: ? Rationale for the rules ? Summarising the rules ? State of play (focus of the talk)
Other aspects in relation to GMP and GDP
3
RULES FOR ACTIVE PHARMACEUTICAL INGREDIENTS
4
Definition of API
Any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis.
5
Objectives
Increased compliance with good manufacturing practices for all API manufacturers
Adding official oversight to the business-to-business controls
Promote dialogue and cooperation on good manufacturing practices at global level
6
Starting point
Trust and cooperation between regulators in key regions
Not "identical rules" as in the EU, but "equivalent protection"
Internationally-accepted guidelines (ICH, WHO, PIC/S)
7
New rules for imported API
Non-EU country
"Written confirmation" needed
unless: Non-EU country is 'listed` ("waiver 1") or, exceptionally*
EU GMP certificate following inspection by an EU country ("waiver 2")
* to secure supplies of medicines
EU country
8
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