CHANGE MANAGEMENT OF DRUG PRODUCTS REGISTRATION CONDITIONS: NEW ICH Q12 GUIDELINE

Cover Page

Abstract


Introduction of amendments to the registration dossier is the responsibility of the marketing application holder (MAH). Increased knowledge on pharmaceuticals, its manufacturing and control processes can reduce the number of documents submitted to the regulatory authorities. The existing requirements establishing the procedure for the introduction of amendments differ in terms of change classification, period of notification of regulatory authorities, ways of conformity validation of pharmaceutical properties, etc. ICH proposed draft guideline Q12 «Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management» which covers the problem of harmonization of regulatory approaches to the changes provided in the «Quality» section of CTD during the commercial phase of drug life cycle. The new guideline can be considered as the continuation and elaboration of previous ICH documents. The article provides explanations on the main provisions and regulatory mechanisms introduced by the draft guideline ICH Q12: categorization of post-approval changes, established conditions, post-approval change management protocol, and drug product lifecycle management.


A. P. Meshkovskii

I.M. Sechenov First Moscow State Medical University

Author for correspondence.
Email: osipova-mma@list.ru
ORCID iD: 0000-0003-4901-4625

Russian Federation

Andrei P. Meshkovskii

N. V. Pyatigorskaya

I.M. Sechenov First Moscow State Medical University

Email: meshkvskijj@mail.ru
ORCID iD: 0000-0002-6016-3237

Russian Federation

Natalya V. Pyatigorskaya - PhD, Professor

V. V. Beregovykh

I.M. Sechenov First Moscow State Medical University

Email: beregovykh@ramn.ru
ORCID iD: 0000-0002-0210-4570

Russian Federation

Valery V. Beregovykh - PhD, Professor

Zh. I. Aladysheva

I.M. Sechenov First Moscow State Medical University

Email: zhaladysheva@gmail.com
ORCID iD: 0000-0002-2441-3542

Russian Federation

Zhanna I. Aladysheva - MD, PhD

V. V. Belyaev

I.M. Sechenov First Moscow State Medical University

Email: belyaev-mma@yandex.ru
ORCID iD: 0000-0002-3011-9390

Russian Federation

Vasiliy V. Belyaev, PhD

A. M. Pyatigorsky

I.M. Sechenov First Moscow State Medical University

Email: apyatigorsky@yandex.ru
ORCID iD: 0000-0001-6671-5832

Russian Federation

Alexander M. Pyatigorsky

N. S. Ivashechkova

I.M. Sechenov First Moscow State Medical University

Email: natik_mos@mail.ru
ORCID iD: 0000-0001-5567-8570

Russian Federation

Natalia S. Ivashechkova

  1. FDA Guidance for Industry: SUPAC-IR Immediate Release Solid Oral Dosage Forms, Scale ― Up and Post-approval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, In Vivo Bioequivalence Documentation, Guidance November 1995 [Internet]. US FDA; 1995 [cited 2018 May 29]. Available from: http://academy.gmp-compliance.org/guidemgr/files/1-6-8.PDF.
  2. Commission Regulation (EC) No 1234/2008 of 24 of November 2008, concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal product [Internet]. Official Journal of the European Union; 2008. 24 p [cited 2018 May 29]. Available from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2008_1234/reg_2008_1234_en.pdf.
  3. Final Concept Paper. Q 12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management dated 28 July 2014. Endorsed by the ICH Steering Committee on 9 September 2014 [Internet]. Geneva, Switzerland [cited 2018 May 29]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q12/Q12_Final_Concept_Paper_July_2014.pdf.
  4. Документ с окончательной концепцией руководства Q12: Технические и регуляторные аспекты управления жизненным циклом лекарственного препарата. ICH. В кн.: Руководства ICH для фармацевтической отрасли. Качество. — М.: Профессия; 2016. ― C. 752–757.
  5. Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management [Internet]. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Guideline. Draft version. Endorsed on 16 November 2017 [cited 2018 May 29]. Available from: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm609205.pdf.
  6. Ramanadham M, Chief B. ICH Q12 Perspectives: “The Robust PQS”. FDA; 2015 [cited 2018 May 29]. Available from: http://pqri.org/wp-content/uploads/2015/10/07-ICH-Q12-robust-PQS-Ramanadham.pdf.
  7. Kishioka Y. How Will ICH Q12 Fly in Japan? [Internet]. Pharmaceuticals and Medical Devices Agency (PMDA). CMC Strategy Forum Japan; 2017 Jan 4–5; Tokyo, Japan [cited 2018 May 29]. Available from: https://www.pmda.go.jp/files/000221767.pdf.
  8. Nashabeh W. Analytical Sciences in Biotechnology. Opportunities and Challenges [Internet]. Basel, Switzerland: F. Hoffmann La-Roche [cited 2018 May 29]. Available from: https://pdfs.semanticscholar.org/presentation/9d1b/70f5d8f20a1a8be7b8d432169f9a11ca2f4d.pdf.

Views

Abstract - 13

PDF (Russian) - 3

Cited-By


PlumX



Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.