Aktualności rejestracyjne

Przedstawione poniżej informacje pochodzą ze stron internetowych następujących agencji/organizacji: Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Ministerstwo Zdrowia, Główny Inspektorat Farmaceutyczny, Europejska Agencja ds. Leków (EMEA), Komisja Europejska – Przedsiębiorstwo i Przemysł, Europejski departament ds. Jakości Produktów Leczniczych, EudraLex, Brytyjska Agencja ds. Regulacji Leków i Produktów Ochrony Zdrowia (MHRA), Amerykańska Agencja ds. Żywności i Leków oraz inne europejskie agencje rejestracyjne.


Miesiąc:
Szukaj
2010-09-02
Polish Ministry of Health: Regulation project relating to the method of submission of the medical devices

2010-09-02
MHRA: Variations legislation 2010 - details of our experience to date, submissions audit and update to FAQs

2010-09-02
MHRA: First draft of the consolidated medicines regulations

2010-09-02
EMA: Herbal Medicinal Products: Valeriana/Humulus, Valerianae radix/Lupuli flos, Valeriana officinalis L. / Humulus lupulus L.

2010-09-02
Polish Ministry of Health: The project of the Act related to the change of the Pharmaceutical Law

2010-09-02
Polish Ministry of Health: Regulation project relating to the fees for issue of medical devices

2010-09-02
FDA: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 12 Analytical Sieving General Chapter

2010-08-26
Polish Office of Registration: Statement concerning the terms for batch number and expiry date to be used on inner labelling.

2010-08-26
EMA: Scientific guideline: Guideline on clinical investigation of medicinal products in the treatment of epileptic disorders

2010-08-26
HMA: Additional Data requested for New Applications in the Mutual Recognition and Decentralised Procedures

2010-08-26
FDA: Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment

2010-08-26
MHRA: Variations legislation 2010 - details of our experience to date, submissions audit and update to FAQs

2010-08-19
FDA: Guidance for Industry Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use — Small Entity Compliance Guide

2010-08-19
EMA: Regulatory and procedural guideline: Guidance on centrally authorised products requiring a notification of a change for update of annexes

2010-08-19
EMA: Regulatory and procedural guideline: Guideline for the specifications of e-submissions of parallel distribution notification documents

2010-08-13
EMA: Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials

2010-08-13
EMA: Terms of reference and procedures for participating authorities (manufacturers of medicinal products)

2010-08-13
MHRA: Publication of assessment reports for European Article 45 and 46 paediatric work-sharing procedures

2010-08-11
EMA: Scientific guideline: Guideline on quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines

2010-08-11
EMA: Scientific guideline:'Guideline on the clinical investigation of medicinal products for the treatment of attention deficit hyperactivity disorder (ADHD)' (EMEA/CHMP/EWP/431734/2008)

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