EU2 8 : SCI ENCE MEDI CI NES HEALTH, A REGULATORY SYSTEM FI T FOR - PowerPoint PPT Presentation

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

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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