Regulatory Strategy Flashcards by assumpta widak

EMA responsibility

for the scientific evalution, supervision and safety monitoring of Medicines in the EU

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EMA responsibility

protects public and animal health in 28 EU Memeber states, and also in th eEuropean Economic Area

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what are the Key responsibilities of the EMA (1)

Does not directly work on application but delegates the central applications to the national authorities

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what are the Key responsibilities of the EMA (2)

issues a recommendation to grant or decline MA

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the MAs is granted by who?

European Commission

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Heads of medicines agencies (HMA) is?

a network of the heads of the national competent authorities (NCA) whose organisation are responsible for the regulation of MP for human and veterinary use

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A Marketing Authorisation is

License to sell a medicinal product
Applied by pharamceutical company
granted by competent authroity
Assessemnt is benefit/risk based on (safety, efficacy and quality)

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How to obtain a Marketing authorisation

Centrailzed procedure
mutual recongnition procedure( Decentralized procedure
National procedures

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Type of application

Full or full-mixed application (complete dossier)
Generic medicinal product application
Hybrid medicinal product
Similar biologic product 
Well established use
Fixed dose combination
informed consent

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Full application

full dossier, quality, nonclinical and clinical data

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Generic

Reference product on the market on less than 8 years
Sama qualitative, quantitative composition
same pharamceutical form
bioequivalence

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Hybrid (mixed) application

Additional non-clinical/clinical data in case:
Product does not meet definition of generic
No BE
changes in the API
Change to API, therapeutic indication, strength, pharamceutical form or route of adminstration

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Biosimilars

Additional non-clinical/clinical data in case:
Product does not meet definition of generic; esp. Differences relating to raw materials or differences in manufacturing process of biological product and reference product

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Well estabished use

WER use of API for at least 10 years

Non-clinical and clinical trial result replaced by literature

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Fixed combination products

API used in composition of authroised MPs but not in combination
New non-clinical and clinical data relating to the combination required

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informed consent/Duplicat

MAH allows refernce to data
Product does not meet definition of generic; esp. Differences relating to raw materials or differences in manfacturing prcess of biological product and reference product

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National procedure is currently only for?

MA in one single EU MS
With No existing MA in any other MS and No pending application in any MS
National phase MRP

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Mutual recongnition/Decentralised procedure is intended for?

Applications for MA in more than one MS( obligatory)

open for all application which do not fall under obligation for CP

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Which application full into the MR/DP?

New API, generic, informed consent, bibliographic applications, known substances in new
combinations, line extensions, herbal medicinal products, homeopathic products

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what are other attributes of the MRP/DCP?

flexible choise of MS (CMS/RMS)
different trade names and MAH
possibility of repeating the procedure

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Timeline for the MRP

Applicant submit application to the RMS and CMS
RMS validates the application (90 days)
RMS distributes assessment report to CMs
CMS validates the application (90 days)
CMS approves the AR
MA in each of the CMS

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Timeline for the DCP?

Applicant submit application to the RMS and CMS
RMS validates the application (70 days)
RMS distributes the preliminary assessment report to CMS (35 days)
-RMS sends preliminary assessment report and all comment of the CMS to the applicant
-Clock stops, applicant repsonds, clock runs (15 days)
RMS sends draft AR to the CMS and applicant
-CMS approved the AR (90 days)

MA in each of the RMS and CMS

Role of the RMS?

provides regulatory and scientifc advide
coordintes Central point between MAA and CMS
Issues Assessemnt report
Referes to CMDh
informs EMA if after referral no consensus
informs MAA and CMS after positive conclusion
Issues FAR (Finals assessment report)
Publishes AR

the choice of the RMS is based on?

regulatory, strategic and commerical reasons

what is set in the MRP?

RMS, where dossier was filed nd appoved nationally

what does Referral means?

if non consent between authorities--> automaticall into referral

why do we need the referral?

to solve potential safety risk issues (PSRPH) which cannot be solved during procedure

are new data allowed in the referral?

what happend if there is no agreement in the referral?

move to CHMP by EMA for referral

withdrawal in MRP?

at any time, except after PSRPH has been raised

what happend after withdrawal (MRP)

automic referral to CMDh

withdrawal in DCP?

at any time, except during assessement step II once PSRPH has been raised

when is the withdrawal (DCP)

after Day 120--> automic referral to CMDh

Repeat use MRP involved?

include fuher CMs | all ongoing procedures to be finalizes and dossier up-date before entering repeat -use

which dossier are update includes in repeat -use MRP

– Reponses to previous procedures; variations/ renewals – Commitments to initially granted MA must be fulfilled – Additional data to comply with latest requirements, e.g. Risk Management Plan, Environmental Risk Assessment ( to be added via variation) – CTD format – If necessary new studies according to new standards

CP allows?

Allows the MAh ro market the medicine and make it available throughout the EU on the basis of a single MA

CP is compulsory for?

• Products derived from biotechnology • Advanced Therapy Medicina Products (ATMPs) (gene therapy, somatic cell therapy, tissue engineered) • Orphan medicinal products • Medicinal products for human use which contain an API authorised in the Union after 20 May 2004 and which are intended for the treatment of AIDS, cancer, neurodegenerative disorders or diabetes.

CP is optional for?

* Medicinal products that contain an API not authorised before 20 May 2004, * Constituting a significant therapeutic scientific or technical innovation, or * For which an EU authorisation would be in the interest of patients.

it is possible to obtained a duplicate MA in CP?

yes

know the CP timeline application

do you know it?

the EMa prodcut team is made out of?

Product team leader (PLT) and product Team members

PLT and PTM?

Nominated by EMA Responsible for handling procedural aspects Both pre-and post authroization phases

PLT is primary conat for? (know to draw the trinagel)

the applicant

Potential option in the CP are

* Accelerated review * Exceptional circumstances * Conditional approval * Orphan drugs * Options for small and medium sized entreprises (SME)

Stategic choices: What is the legal basis of your medicical product? it depends on?

– Type of API(s)  new, well-known, if old: how old, chem.-def. or herbal, – Number of API(s)  known or new combination – Dosage format – Available bibliographical data

if you there are already existing comparable Mas for your product, what do you go for?

– WEU – generic – informed consent

Strategic Choices: Market considerations | 1. Targted markets?

All E member states | Limited number of countires

Strategic Choices: Market considerations | 2. Expand later

– 1st wave with main markets: DCP | – 2nd wave with further markets: RU-MRP

Strategic Choices: Market considerations | 3. Capability of the organization

– Ability to market throughout the EU

Strategic Choices: Market considerations | 4. New availability on other countries

– National MA (for many years) in one country  MRP

Strategic Choices: costs /Fees | CP

one fee

Strategic Choices: costs /Fees | National; MRP/DCP

individual fee per memeber state | difference between RMS and CM role

Strategic Choices: Timelines | What is the feastes procedure

National: individually per country (DE: 7 months but…) – MRP: national + 90 days (national phase not fixed ) – DCP: 210 days (clock stop ) – CP: 210 days

Strategic Choices: Name | what is my branding strategy

-CP: One single name! | – MRP / DCP: names can be different in MS