Active pharmaceutical ingredient: Any substance or mixture of substances intended to be used in the manufacture of the medicinal product and that, when used in the production of the drug, becomes an active ingredients of the medicinal product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of diseases or to affect the structure and function of the body.
In EU, API's classified as:
- New active substances
- Existing active substances not included in the European Pharmacopoeia (Ph.Eur.) or the pharmacopoeia of an EU Member State
- Active substances included in the Ph.Eur. or in the pharmacopoeia of an EU Member State
Depending on the kind and classification of the active substance, the required data may generally be submitted in one of the following
a. Certificate of suitability to the monograph of the European pharmacopoeia (CEP)b. Active Substance Master File (ASMF) procedure or EDMFc. Full details of manufacture
- For new active substances option (b) or (c) would apply.
- For existing substances option (a) would apply, it has the advantage of generally avoiding any subsequent reassessment. Option (b) and (c) are also apply.
Scope:
CEP - Applicable to Pharmacopoeial substances only (active substance or excipient)
ASMF - Applicable to active substances only ( new or pharmacopoeial)
Differences between CEP & ASMF:
ASMF:
- Full dossier sent by API manufacturer to National Authorities
- It consists two parts: Open part and closed part
- Applicant’s part sent by API manufacturer to MA applicant or holder of medicinal Product
- Letter of access (to be sent by API manufacturer)
- Assessment of ASMF by each national authority in the context of assessing a specific marketing authorisation application or variation for medicinal products.
CEP:
- Full dossier sent directly by manufacturer to EDQM
- Single evaluation centralised at EDQM
- By assessors nominated by national authorities / Certification Steering Committee
- Independent from marketing applications of medicinal products
- Certificate including annexes (additional tests to be performed) granted to manufacturer who supplies a copy of it to its users
Advantages of the CEP
- Easier management of RA documentation for API manufacturer (no open part)
- Savings of time and resources
- Easier management of MAA - replaces main part of 3.2.S
- CEP accepted in all Ph. Eur. Member states (36) + others (eg. Canada, Australia, Morocco, New Zealand etc.)
References:
So, what happens after we receive our CEP? Does that mean we are now an API manufacturer? Does that mean that our product(s) are now API?
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