API – the new approach for third countries – w hat are the consequences – should w e expect shortage of m edicinal products in the country? Perspectives from an acceding country EU2 8 : SCI ENCE MEDI CI NES HEALTH, A REGULATORY SYSTEM FI T FOR THE FUTURE Dubrovnik, Croatia, 6 -7 May 2 0 1 3 Mr Stefano Soro, Head of Unit Medicinal products: quality, safety and efficacy Directorate General for Health and Consum ers Health and Consumers
The European Union ( EU) Directive 2 0 1 1 / 6 2 / EU - m ain contents Obligatory Actors in the Active ‚Online safety pharmacies‘ supply chain substances, features quality 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 ACTI VE PHARMACEUTI CAL I NGREDI ENTS 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 I ncreased com pliance w ith good m anufacturing practices for all API m anufacturers Adding official oversight to the business-to-business controls Prom ote dialogue and cooperation on good m anufacturing practices at global level 6
Starting point Trust and cooperation betw een regulators in key regions Not “identical rules” as in the EU, but “equivalent protection” I nternationally-accepted guidelines ( I CH, W HO, PI C/ S) 7
New rules for im ported API EU Non-EU country "W ritten confirm ation" needed country unless: Non-EU country is 'listed‘ (“waiver 1”) or, exceptionally* EU GMP certificate following inspection by an EU country (“waiver 2”) 8 * to secure supplies of m edicines
New rules on API “W ritten confirm ation” Confirming compliance of the plant with GMP or equivalent rules Issued by the competent authority of the exporting non-EU country Issued per site and API (not per batch or consignment) One written confirmation can cover several APIs Duration of validity is established by exporting non-EU country Template is here: http: / / ec.europa.eu/ health/ files/ eudralex/ vol- 4/ 2012_06_19_template.pdf 9
New rules on API “W aiver 1 ” : non-EU country is "listed" List is set up by the European Commission following a request from a non-EU country The list is based on an assessm ent of equivalence of: GMP rules Regularity of inspections Effectiveness of enforcem ent of GMP Rapid alert system for non-com pliant producers So far, seven countries have submitted requests 10
New rules on API “W aiver 2 ” : "Exceptional circum stances" " Exceptionally ", and where this is necessary to ensure the availability of medicines, the need for the written confirmation can be waived by a EU Member State if a EU Member State has inspected the plant and found it compliant. 11
State of play Countries that have inform ed us of the intent to issue "w ritten confirm ation", or that have started issuing "w ritten confirm ation": India, China, Israel, Mexico, Canada, Taiwan, Turkey, South Africa, Ukraine; Korea; Singapore; Russia Countries that have applied for "listing": Switzerland, Israel, Singapore, Australia, Japan, U.S., Brazil Strengthened coordination of inspections ( EMA) on the basis of survey of the heads of m edicines agencies 12
Actions needed by the different actors Finished dosage m anufacturers in the EU: To inform suppliers in third countries of incoming rules EU-authorities: To inform of incoming rules; verify whether additional Member State inspections are needed to ensure supply Suppliers in third country: To obtain 'written confirmation' for the manufacturing plant Non-EU country authorities: To prepare for issuing the written confirmation; assess possibility to request Commission to be 'listed' 13
14
Additional inform ation published by the European Com m ission "Questions-and-answers" document: http: / / ec.europa.eu/ health/ human- use/ quality/ index_en.htm Information leaflet: http: / / ec.europa.eu/ health/ files/ documents/ activ e_pharmaceutical_ingredients_leaflet_en.pdf 15
Other aspects in relation to GMP and GDP • GDP ( m edicinal products) • GDP for API • Risk assessm ent for excipients • GMP for API http: / / ec.europa.eu/ health/ human- use/ falsified_medicines/ index_en.htm 16
• Many thanks! • Sanco-pharm aceuticals-d6 @ec.europa.eu 17
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