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Marina Hurtado MiraMarina Hurtado MiraRegulatory Affairs AssociateRegulatory Affairs Associate
•Regulatory Affairs Department
•Role Regulatory Affairs
•Marketing Approvals Ways
Centralised Procedure
Mutual Recognition Procedure
National Procedure
•Post-approval
•European Medicines Agency’s Role
•Evaluation by EMA
REGULATORY AFFAIRS DEPT
MAA – Marketing Authorization Application
Prepare and submit the documents to regulatory
agencies
To give strategic and technical advice to the
departments; production, QC dept, QA, price and r;
marketing…
ROLE OF RA
Marketing Approval Ways
Centralised Procedure (CP)Mutual Recognition (MRP) /
Decentralised Procedure (DCP)
National Procedure (NP)
Better resources utilisation
Harmonised scientific opinions
Harmonised information for doctors
Centralised Procedure
MA
SmPC
PL
Labelling
Invented name
HIV/AIDS, cancer, diabetes,
neurodegenerative diseases, auto-
immune and viral diseases;
medicines derived from:
-biotechnology processes
-advanced-therapy medicines, orphan
drugs
HIV/AIDS, cancer, diabetes,
neurodegenerative diseases, auto-
immune and viral diseases;
medicines derived from:
-biotechnology processes
-advanced-therapy medicines, orphan
drugs
OPTION APPLICATION
Mandatory
Mutual Recognition Procedure / MRP
National licensed approved 1 member State RMS
RMS: Reference Member StateCMS: Concerned Member State
During recognization ask others
countries to
recognise the positive
opinion
NATIONAL PROCEDURE / NP
Evaluation by AEMPS
Authorisation by AEMPS
New National Application / NNA
Dossier to AEMPS
Validation
Evaluation
Authorisation
RAEFAR Nees / eCTD
POST-APPROVALDevelopment of strategies
-changes to manufacturing process
-changes to product characteristics
-additional indications
Responses to the Agencies
Organisation for future issues
Discussion of variation strategies and timing
EMA
AGENCY’S
ROLEEvaluation of applications – efficient and transparent
Provision of Advice (optional)
Control of safety
Evaluation for orphan designation
Evaluation for Pediatrics investigations - PIP
Provide good and independient information
96 applications
EU is a Single for pharmaceuticals
The main scientific principle used in the evaluation of medicines is the benefit/ risk balance, based mainly on quality, efficacy and safety
Evaluation by the European Agency
Evaluation by the European Agency
Adopts an opinion
SCIENTIFIC COMMITTEES
CHMP
CVMP
COMP
HMPC
CP – PIP
ATC
Chairman
Vice Chairman
5 experts (area) co-opted members
1 per month
27 MS
Evaluation by the European Agency
CHMP Adopts an opinion “Day 210”
- Marketed or not
This opinion “ European Commission “ 270 days
- The ultimate authority for granting marketing
authorisations in the EU
Marketed 3 Years – Sunset Clause
Evaluation by the European Agency
Authorised
EPAR European Public Assesment Report
EPARBriefSmPC; PIL; Label Authorised products
http://www.emea.europa.eu/ema/
1MAA - EU1MAA - EU
1 MAA / 1 MAA / differents differents countriescountries
1 MAA /Country1 MAA /Country National ProcedureNational Procedure
MRPMRP DCPDCP
CPCP
Conflict; disputeConflict; dispute
ReferralReferral
PROCEDURES / REFERRAL
mhmpharma@gmail.com
www.pharmatalents.es
You can find us in Pharma Talents / LinkedIn &
Follow us inTwitter @talentspharma
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