TOPRA IN SWITZERLAND
Authorisation of medicinal products already authorised in foreign countries (Article 13, TPA)
U.Hopff 18.10.2011Regulatory Affairs Manager
Vifor Pharma
The Law
„If a medicinal product or procedure is alreadyauthorized in a country with a comparablecontrol system for medicinal products, the
results of tests carried out for this purpose shallbe taken into account“
Paragraph 13 TPA
Spirit and Purpose of the Law
To take into account the results of tests carried out by countrieswith comparable control system for medicinal products:
AUSTRALIA, CANADA, EU and EFTA Member States, JAPAN, NEW ZEALAND, SINGAPORE, USA
To treat marketing authorisation applications fast and rational
Use resources of SwM well-directed and risk based
Reduce processing time for authorisation and cost by a third
Swissmedic decides whether Art. 13 can be applied
Art. 5a VAM: The results of reference authority are taken intoaccount for marketing authorisations and changes if:
a. The submitted documentation including modifications from the foreign procedure is not older than 5 years.
b. All results of examination and decisions from theforeign procedure are submitted.
c. Documents include Swiss specific requirementsespecially for product information.
d. Documents in Switzerland‘s official language or in English.
Legal Basis
Legal Basis
Art. 5b VAM: Medicinal products with known active substances (KAS)
1. KAS by foreign authority but not CP or FDAExamination of evaluation report but might carry out ownscientific evaluation if:
Prior rejection or withdrawl in Switzerland Rejection by foreign authorities
2. KAS with CP or FDA authorisationSwM refrains from examination of the evaluation report.Analysis of background, context, PhIL, safety signalsexcept:
Material differences Previous rejection or withdrawal in Switzerland
Art. 5c VAM: Medicinal products with new active substances and their newindications (NAS)
Generally Swissmedic carries out own evaluation may howeverreduce assessment in justified cases:
Orphan drugs
Life-threatening / debilitating disease
Considerable therapeutic advantage
Central EMA or FDA authorisation
Legal Basis
Legal Basis
Art. 5d VAM: Parallel procedureSwitch from national procedure to an evaluation according toparagraph 13
Status of application for authorisation in foreigncountries
As soon as EMA issues recomendationsubmit corresponding request
Documentation requirements
CTD Module 2-5 submitted to the reference authority
+CTD Moudule 1 submitted to the reference authority
+CTD Module 1 according to Swiss requirements
Confirm that the documentation including modifications and/oradditions since the decision by the foreign authority is identical .
Documentation submitted to thereference authority
All results of examination and decisions on the part of the reference authority including correspondence
EU Responses to Questions, EU Assessment Report, EU Decision, FDA Decision (incl. FDA Assessment Report)
Modifications and or additions since the decision by the foreign authority
Information regarding safety signals
GLP/GMP/GCP confirmation
Paediatric Investigation Plan (PIP)
Drug Master File (DMF)
Documentation requirements
SWISS MODUL 1
Administrative data Request of Article 13 TPA applicationTick box on application form
Checklist for formal control relating to Article, 13 TPAConfirm that requirements are fulfilled
Product Information Swiss specific information (e.g. pregnancy, storageinstructions, language requirements)Θ word-by word acceptance of the reference countries SPC not possible except EMA decision (EU-SmPC )
Documentation requirements
What differences between the foreign andapplication to SwM are allowed?
Differences of the place of manfacture of the finished product
Differences related to batch release
Differences related to primary packaging
Differences to quality control
Differences to the product designation
Formal Control
Guidances andDocuments:
Administrative OrdinanceAuthorisation of medicinalproduct already authorised in foreign countries (Paragraph 13 TPA)
Guidance on applicationsaccording to Paragraph 13 TPA foreCTD applications
Formal Control Art. 13 andformal control Art 13 CTD
www.swissmedic.ch
Documents for eCTDsubmissions
Swiss Module 1 + Reference dossier + Correspondence
Initial Swiss eCTD sequence contains only Swiss Modules 1
If accepted according to Art. 13 then submit consolidationsequence (incorporate Module 2-5 in Swiss eCTD)
Time Table for RX-registrations
(approximately)Standard-verfahren
nach Art. 13 (CP)*
nach Art. 13 (DCP/MRP)**
Administrative preparationby MAH
30 50 50
SwM: formal control 30 30 30
Marketing Authorisation 300 200 200-290
BAG:Preparation by MAH 30 30 30
BAG: Decision andadmission to SL
120 120 120
Total to Launch 510 430 430-520
Time Table Paragraph 13 TPA
* CP 297 + clock stop / Date of Comission Decision**MRP 440 + clock stop /Date of Day 90**DCP 250 + clock stop /Date of MA in RMS
Responsibilities after authorisation
Conditions that are imposed by the reference authorities are that havenot yet been fulfilled at the time of authorisation are also imposed bySwissmedic
Decisions taken by the reference authorities concerned the fulfilment ofconditions must be forwarded to the Agency
All relevant information such as correspondence in relation to marketsurveillance after authorisation in a reference country
Examples and possible issues atsubmission
Identical documentation not always possible:−e.g. FDA NDA format is not identical with CTD format, international standards BP, USP not always identical withPh.Eur./Ph.Helv requirements.
Timelines unclear:−e.g. procedure lasted more than 2 years
Swissmedic did not approve indication in previous applicationleads to own evaluation based on earlier concern.
Know active substance with slightly different indication in thereference country.
Safety concern and other questions by Swissmedic
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