Conditional Marketing Authorisation How early access to medicines has helped patients from 2006 to 2016
CMAs
What it is an EU early access route for medicines for medicines that fulfil an unmet medical need only granted if the benefit of immediate availability for patients is greater than the risk of less comprehensive data than normally required valid for a year; can be renewed annually comprehensive data is generated post-authorisation, to agreed timelines
24 14 3
Target debilitating or life-threatening conditions Are orphan medicines
Address emergency situations linked to a public health threat
By therapeutic area
Scope includes
17
9
Oncology
Infectious diseases
medicines to target seriously debilitating or life-threatening diseases
3
medicines to fight public health threats in emergency situations (e.g. a pandemic)
1
Neurology
Ophthalmology
medicines to treat rare diseases
107 post-authorisation obligations (of these, 57 obligations were fulfilled before June 2016)
Interim results of a clinical trial Additional analysis Quality data Other measures
Early (6-12 months) >1 year early Late (1-6 months) Late (6-12 months)
of specific obligations were completed within specified timelines
3 1
1
1
1
1
1
1
2 On average, a CMA is converted into a standard marketing authorisation within 4 years.
EMA’s Committee for Medicinal Products for Human Use (CHMP) reviews all data collected annually to decide about a further renewal of the CMA or its conversion into a standard marketing authorisation.
Due date +/- 1 month
3
2
4
By year
3
≈70%
of completed specific obligations did not have major changes to their scope
2
>90%
33 15 4 1 2 2
Final results from clinical studies or pool of studies
1
78 9 8 3 9
How timely was the submission of specific obligation results?
3
Categories of specific obligations imposed to companies
Conditional MA Conversion pending MA withdrawn for commercial reasons
» The cut-off date for data collection is June 2016
Conditional Marketing Authorisation - How early access to medicines ...
risk of less comprehensive data than normally ... Categories of specific obligations imposed to companies. 78. 9. 8. 3. 9 ... Additional analysis. Quality data.
The validation period between submission date and start date is usually sixteen calendar days. (**) Comments from PRAC and CHMP members are not made available to Marketing Authorisation Holders. (***) An updated AR is optional and dependent on the co
Oct 7, 2016 - Applications by marketing authorisation holders (MAHs). Guidance for ... Issues identified during validation will be notified to the MAH via email.
Jan 1, 2018 - ... has introduced a number of measures via new or revised texts in the human field to promote 3Rs. These requirements are published in Supplement 9.3 and are in force from 01/01/2018. 1 Correction in title of document. 2 Available at h
Jan 1, 2018 - highlighting recent measures in the veterinary field to promote reduction ... Experimental and Other Scientific Purposes (Council of Europe), tests performed in animals must be carried out in such a ... In the EU, after 1 January 2013,
The EMA emphasises the importance of pre-submission meetings between applicants and the EMA/(Co-. ) Rapporteur. Pre-submission meetings (which should take place approximately 7 months prior to the anticipated date of submission of the application) ar
Jan 1, 2017 - Understand the access to EudraVigilance provided via the EudraVigilance Data Analysis. System (EVDAS). ⢠Be familiar with the EVDAS user ...
Feb 16, 2017 - usually apply for oral explanations at CVMP Working Parties and other CVMP ... explanation to the company, and also specifies the number of ...
letter should contain the template table to facilitate submission and registration. ..... contact us using the following email address: [email protected].
Jun 19, 2012 - QRD Product Information Template with explanatory notes ...... An automated 'acknowledgement' e-mail is sent from the system confirming ...
May 4, 2018 - and whose bioequivalence with the reference medicinal product ...... preferably be given on the line of text directly below the complete name.
Pharmacovigilance System Master File be physically located and administered outside EU if it ..... stability studies to support a Type IAIN variation before making an immediate notification1 because the change will not ...... product protected either
Dec 9, 2013 - 6564. 3.21. Can a new indication based on less comprehensive data be added to an already ...... variation complies fully with the data and documentation requirements as specified in the Variations ...... continuously at its disposal the
30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom. An agency of the ...... should implement accordingly when the adopted changes are applicable to their MA. ...... 180. 13.11. When ...... Access to unpublished clinical data ca
How is a marketing authorisation application pre-submission meeting conducted at. EMA? Rev. ...... a new technology or a new application of technology is used for the development or the manufacture of the ..... applicable fee, see question "What fee
13.11. When should I register my studies in the EU PAS Register? ...... The Agency aims to respond to your query within 5 working days. ...... the MA or since the last renewal, making reference to relevant new information in the public domain.
To whom should I submit follow-up data requested after the conclusion of a PSUSA ...... contact us using the following email address: [email protected] ...... An automated acknowledgement email is sent from the system confirming ...
and to notify the Agency and (Co-)Rapporteurs of a 'real' submission date. The HMA-EMA ...... However, the fact that the mock-up has to be a real example of the sales presentation implies that the mock-up ...... The purpose of specifying study milest
