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APIC "the Active Pharmaceutical Ingredients Committee"
is a Sector Group within Cefic (the European Chemical
Industry Council).
APIC's membership consists of companies from different
pharmaceutical industry sectors, all involved in the
manufacture of APIs. This provides an ideal basis for
developing and communicating a balanced, holistic view
on API-related regulations and guidelines.
Mission:
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To
promote the use of compliant APIs in medicinal products
to ensure patient safety
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To represent the interests of
pharmaceutical and chemical companies producing APIs
and intermediates in
Europe by being recognized experts who advance and influence
the global GMP
and Regulatory environment.
Strategic Objectives:
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Level Playing Field: to strongly advocate
regulatory compliance in all global markets and its enforcement through
inspection.
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Post approval change authorisation: to put
responsibility to manage change into the hands of industry.
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Harmonisation: to support global harmonisation in
the fields of quality and regulatory affairs.
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Networking/ Advocacy: to improve our contacts and
increase the profile of APIC with all relevant stakeholders.
Cooperation and Contacts
In order to achieve its mission
APIC is in regular contact with national- and intergovernmental
bodies, such as:
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European Commission (EC)
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European Medicines Agency (EMEA)
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European Directorate for the Quality of Medicines (EDQM)
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European
Parliament (EP)
- US
Food and Drug Administration (FDA)
-
International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for
Human Use (ICH)
-
World Health Organization (WHO)
-
Council of Europe (CoE)
-
Pharmaceutical Inspection Cooperation Scheme (PIC/S)
In addition APIC seeks to
coordinate the representation of the interests of its
members with other related industry
associations, such as:
- European Federation of
Pharmaceutical Industries and Associations (EFPIA)
- Pharmaceutical Research and
Manufacturers of America (PhRMA)
- European Generic medicines
Association (EGA)
- International Pharmaceutical
Excipients Council (IPEC)
- International Federation for
Animal Health (IFAH)
- US Generic Pharmaceutical
Association (GPhA)
- European Association of
General Public Specialties (AESGP)
- US Synthetic Organic
Chemical Manufacturers Association (SOCMA)
APIC participates in and contributes to
conferences, round tables and workshops dedicated to APIs
and intermediates in order to monitor developments and
present the views of APIC. Since 1998, APIC has been
organising the annual “APIC/CEFIC European Conference on
Active Pharmaceutical Ingredients”, which has developed
into the number one conference in Europe on GMP- and
RA aspects of APIs and intermediates.
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