Drug Approval Procedures-European Union

Before starting off on drug approval procedures in European Union, I would like to present a table on European Union member countries and Non-European union member countries since the drug approval procedures are not necessarily the same throughout the Europe.

European Union member countries	Non-European union member countries
Austria	Iceland *
Belgium	Norway *
Bulgaria	Switzerland
Cyprus	Serbia
Czech  Republic	Montenegro
Denmark	Croatia
Estonia	Bosnia-Herzegovina
Finland	Macedonia (Former Republic of Yugoslav)
France	Albania
Germany	Andorra
Greece	Belarus
Hungary	Moldova
Ireland	Monaco *
Italy	San Marino
Latvia	Liechtenstein *
Lithuania	Vatican City
Luxembourg	Russia
Malta	Ukraine
Netherlands	Georgia
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom

The following Drug approval procedures are only intended for EU member countries and non EU member countries indicated with “*” in the above table.

1.Centralised Procedure-

• The centralised procedure, allows applicants to obtain a marketing authorisation that is valid throughout the EU (27 EU member countries).

• Application to market a medicinal product that is eligible for the centralised procedure is sent to European Medicines Agency (EMA) which is assessed by the Committee for Medicinal Products for Human Use (CHMP)

• The time limit for the evaluation procedure is 210 days

Centralised procedure is mandatory for the following-

• Medicinal products manufactured using biotechnological processes like recombinant DNA, Hybridoma technology, controlled gene expression, tissue-engineering.

• Orphan medicinal products

• Products containing a new active substance which was not authorised in the Community before 20 May 2004 and which are intended for the treatment of AIDS, cancer, neurodegenerative disorder or diabetes

Centralised procedure is optional for the following-

•  New active substances not authorised in the Community before 20 May 2004

• Products which constitute a significant therapeutic, scientific or technical innovation or for which a Community authorisation is in the interests of patients or animal health at Community level.

2. Decentralised Procedure-

• The decentralised procedure is used for products that have not yet received authorisation in an EU country.

Outline of Decentralised Procedure are-

(i)  Pre-procedural Step

(ii) Assessment step I

(iii) Assessment step II

(iv) National step

Involved members/groups in DCP-

RMS- Reference member state
RMS has the following roles-

-Acts as a link between the applicant (Pharma Company) and the CMSs

-Allocation of procedure number

-Starting the procedure

-Involved in the preparation of preliminary and draft-assessment reports, initial comments on- SmPC     (summary of product characteristics), labeling and package leaflets provided in the dossier.

-Stopping and restarting the procedure, before and after clock stop period.

-Closing the procedure if consensus is reached.

CMS(s)-Concerned member state(s)

-Involved in the approval/disapproval of RMS’s – preliminary and draft-assessment reports, initial comments on SmPC (summary of product characteristics), labeling and package leaflets

-Involved in earlier stages of DCP to avoid disagreements between CMS and RMS.

The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh)

CMDh has following responsibilities-

-In case of disagreement between the Member States involved in a Mutual recognition or decentralised procedure on the Assessment report, the summary of product characteristics, the labelling or the package leaflet on the grounds of “potential serious risk to public health”, the points of disagreement are considered by the CMDh. The CMDh uses its best endeavours to reach agreement on the action to be taken within the 60 day time period foreseen in the legislation.

-To lay down, yearly, a list of medicinal products for which a harmonised summary of product characteristics should be drawn up, to promote harmonisation of marketing authorisations across the Community.

The Committee for Medicinal Products for Human Use (CHMP)-

If consensus is not reached at CMDh the points of disagreement will be referred to CHMP.

Note:

-RMS and CMSs are the countries where the applicant (pharma companies) intends to get marketing approval for its products

– CMDh and/or CHMP are only involved if there is disagreement between RMS and CMSs.

FLOWCHART OF DECENTRALISED PROCEDURE

3. Mutual Recognition Procedure-

• The mutual recognition procedure is used for products that have already received authorisations in one or more EU countries.

• The mutual recognition procedure is based on the principle of the mutual recognition by EU Member States of their respective national marketing authorisations.

• The drug should already be approved in the selected RMS.

• The time  period for the procedure is less than DCP and CP.

FLOW CHART OF MUTUAL RECOGNITION PROCEDURE

Note : Information on RMS, CMS, CMDh and CHMP is as that provided in DCP.

4. National Procedure-

• It is limited to the initial phase of mutual recognition procedure

• If the drug product is intended to be authorized in only one EU member state.

• Generally, not used now-a days.

Advantages of Drug approval procedures (CP, DCP, MRP)-

• The applicant need not go through the entire cycle of  Dossier filing——-Queries——-Reply to queries——–Approval in all the EU member countries.

• Approval in multiple countries through single procedure

• Time of approval in various EU member countries can be minimised

• Costs can be reduced

Note-

– Any product registered in France can be marketed in Monaco too, as Monaco delegated its responsibility of Drug approval to France.

-Any product authorized in the UK can be automatically sold in the Channel Islands (legally not part of the UK, but owes allegiance to the British Crown)-Iceland has applied for EU membership

References-

1.http://ec.europa.eu/health/authorisation-procedures-centralised_en.htm

2.http://www.bfarm.de/EN/drugs/2_Authorisation/types/euAuthProcs/cp/central-node-en.html
3.http://ec.europa.eu/health/authorisation-procedures-mutual-recognition_en.htm
4.http://www.hma.eu/47.pdf
5.http://wiki.answers.com/Q/Which_European_countries_are_not_in_the_European_Union

Further reading-
1. http://ec.europa.eu/health/files/eudralex/vol-2/a/chap4rev200604_en.pdf
2.http://ec.europa.eu/health/files/eudralex/vol-2/a/vol2a_chap2_2007-02_en.pdf
3.http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/DCP/CMDh-078-2005-Rev3-Clean_2011_09.pdf

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