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

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

Mar 03, 2023 136 likes •310 views

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

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Health and Consumers

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

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The European Union ( EU) Directive 2 0 1 1 / 6 2 / EU - m ain contents

Obligatory safety features Actors in the supply chain Active substances, quality ‚Online pharmacies‘

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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

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RULES FOR ACTI VE PHARMACEUTI CAL I NGREDI ENTS

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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

  • r metabolic action with a view to restoring, correcting or

modifying physiological functions or to make a medical diagnosis.

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  • 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

Objectives

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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)

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New rules for im ported API

Non-EU country EU country

"W ritten confirm ation" needed

unless:

  • Non-EU country is 'listed‘

(“waiver 1”)

  • r, exceptionally*
  • EU GMP certificate following

inspection by an EU country (“waiver 2”)

* to secure supplies of m edicines

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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

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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

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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.

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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)
  • n the basis of survey of the heads of m edicines

agencies

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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'

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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

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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

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  • Many thanks!
  • Sanco-pharm aceuticals-d6 @ec.europa.eu

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