1 / 10

The assessment process in “stringent” authorities

The assessment process in “stringent” authorities. Regine Lehnert. Training workshop: Regulatory requirements for registration of Artemisinin based combined medicines and assessment of data which are submitted to regulatory authorities, February 2009. Synopsis. Dossier requirements

libba
Télécharger la présentation

The assessment process in “stringent” authorities

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. The assessment process in “stringent” authorities Regine Lehnert Training workshop: Regulatory requirements for registration of Artemisinin based combined medicines and assessment of data which are submitted to regulatory authorities, February 2009

  2. Synopsis • Dossier requirements • Pre-authorisation assessment process • Timelines (example) • Post-authorisation assessments

  3. Dossier requirements (I) • Common Technical Document (CTD) ICH (2001) Specification for application dossier for the registration of medicinal products. 5 Modules : • Administrative and prescribing information • Overview and summary of modules 3 to 5 • Quality (pharmaceutical documentation) • Safety (toxicology studies) • Efficacy (clinical studies)

  4. Dossier requirements (II)

  5. Pre-authorisation Assessment (I) • Steps (I) First assessment of the submitted data quality nonclinical clinical (pk/S+E/PhV) letter of deficiency (list of questions) clock-stop

  6. Pre-authorisation Assessment (II) • Steps (II) applicant‘s response assessment approval list of outstanding issues with/without commitmentsassessment of clarifications refusal approval with/without commitments clock-stop

  7. Pre-authorisation Assessment (III) • Timelines: European „centralised“ licensure • First assessment: ≈ 80 days • Response assessment: ≈ 30 days • Assessment of clarifications: ≈ 30 days Of note: European system – involvement of other member states with possibility to comment on each assessment report. → altogether max. 210 days [ → + Commission decision (≤ 90 days)]

  8. Pre-authorisation Assessment (IV) • Assessment templates and guidance • for each discipline • for each phase • available on EMEA website: http://www.emea.europa.eu/htms/human/chmptemplates/artemplates.htm

  9. Post authorisation assessments (I) • Follow-up measures(according to timelines specified in a company‘s letter of undertaking at the time of licensure) • Variations(upon application) • pharmaceutical - major/minor • nonclinical/clinical - major/minor • Renewal(once, 5 years after licensure)

  10. Post authorisation assessments (II) • Periodic Safety Update Reports • 6-monthly for the first 2 years • yearly for the next 2 years • after 5 years (time of renewal) • 5-yearly thereafter • Other pharmacovigilance issues(event-driven), e.g. • urgent safety restriction • DHCPL • class reviews)

More Related