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