Medicinal products marketing authrization procedures

1
Medicinal products marketing authorization
procedures

• https//www.regulatory-affairs.pl/en/medicinal-pro
  ducts.html

2
The basic principles of EU law

• The main types of EU legal acts
• Regulations (Regulation) - do not require
  implementation - apply to all countries, even if
  there are no such records in national law
• Directives not obligatory by itself, but the
  Member States have an obligation to implement
  these provisions into national law
• Scientific and procedural guidelines published by
  the working groups within the EMA ICH, EC, CMD

3
The basic principles of EU law

• Basic legislation for medicinal products
• Directive 2001/83, as amended - regulates the
  requirements for human medicinal products
  including marketing authorization procedures,
  dossier (introduced CTD format), the types of
  applications (so called legal basis - for example
  generic, hybrid, WEU, fixed combination),
  introduces the European Pharmacopoeia (Ph.
  Eur./EP) as a source of basic quality
  requirements
• Directive 2001/82, as amended - the equivalent of
  the above for veterinary medicinal products

4
The basic principles of EU law

• Basic legislation for medicinal products
• Regulation 726/2003, as amended - establishes the
  European Medicines Agency EMA (formerly EMEA)
  responsible for the central procedure and the
  coordination of EU-wide projects (including
  coordination of the development of scientific
  guidelines and procedural cooperation of national
  agencies etc.).
• Directive 2003/94 on EU GMP
• Regulation 1234/2008 introducing a new system of
  post-marketing variations the MRP, DCP and the
  central procedure

5
Marketing authorization procedures

• National procedure
• Mutual Recognition Procedure MRP
• Decentralized procedure DCP
• Central procedure

6
National procedure

• Marketing authorization of a medicinal product in
  single EU country
• Dossier assessment in single country
• Regulated by national legislation of particular
  country

7
National procedure

• Timeline 210 days clock-stop periods
  (suspension of the process for the preparation of
  answers to questions)
• The first stage is a formal validation of the
  application and documentation (fees, completeness
  attached documents etc.)
• After successful completion of this stage the
  dossier is directed to the proper assessment of
  data

8
MRP (mutual recognition procedure)

• Applicable if the medicinal product is already
  registered in one of the EU countries and company
  wants to authorize it in the next EU
  country/countries
• Formally mandatory if the same product has
  already been authorized (the same MAH and the
  same composition) in one of EU countries - the
  aim is the common assessment and as a result the
  same SmPC

9
MRP (mutual recognition procedure)

• A common assessment by all involved countries (so
  called CMS - Concerned Member States)
• Country in which the product is already
  authorized acts as the RMS (Reference Member
  State). RMS is responsible for procedure
  management and preparation of the assessment
  report for the procedure
• The assessment report and the medicinal product
  dossier is then assessed by the CMSs

10
MRP (mutual recognition procedure)

• General principles MRP procedures are defined by
  the Directive 2001/83
• Timeline of the procedure 90 days. Preceded by a
  three-month period to prepare an assessment
  report by the RMS and CMS 14-day validation stage
  for CMS countries which is similar to the
  national procedure validation procedure (fees,
  completeness of dossiers, and formal documents)
• Important there are no clock-stop periods -
  little time to prepare the answers.

11
DCP procedure

• The same medicinal product is to be authorized in
  parallel in several EU countries, and it has not
  been authorized in the EU yet.
• One of these countries is selected as the RMS
  country which is responsible for preparation of
  the preliminary assessment report while the rest
  of involved countries (CMSs) jointly review the
  assessment report and the medicinal product
  dossier
• Timeline 210 days clock-stops
• Its now the most common procedure for marketing
  authorization in the EU

12
Central procedure

• The most complicated and most demanding procedure
• Single assessment and single license issued by
  the European Commission on the basis of EMA
  assessment valid in all EU member states.
• Assessment by chosen countries selected from CHMP
  or CVMP members.

13
Central procedure

• This procedure is mandatory for new therapies for
  HIV / AIDS, neurodegenerative diseases (eg.
  Alzheimer's disease), cancer, diabetes, and
  medicinal products which use recombinant DNA
  techniques.
• The procedure is very expensive and demanding in
  terms of dossier, studies and procedural issues.
• Calendar of procedure 210 days with clock-stop
  periods, similar to the DCP calendar.