Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Technical Regulatory change assessments for worldwide approved medicinal products - complexities in a regulatory non-harmonized and dynamically evolving environment

Gianluca Ronzoni (Abschlußjahr: 2016)

Summary
Language: English
The approval of a medicinal product is commonly granted by Health Authorities (HAs) only if the documentation (pharmaceutical dossier) submitted by an applicant satisfies the regulatory requirements for safety, efficacy and quality.
After obtaining the marketing authorization, the applicant is requested to manufacture and control the pharmaceutical product in alignment with what described in the submitted technical documentation (module 3 of the pharmaceutical dossier) to ensure that the original assessment of satisfactory safety and efficacy remains valid throughout the lifecycle of the product.
In case technical changes are needed to maintain or improve the manufacture of pharmaceutical products, the applicant should have a system in place to assess their regulatory relevance. Through this evaluation the marketing authorization holder guarantees that product quality remains unchanged after change implementation. In addition, it should be determined if such changes must be firstly approved by the HAs before being implemented, in agreement with the global regulatory requirements for post-approval changes. Such assessments are the primary scope of change control.
The technical drug regulatory affairs manager plays a key role in the change control process, as one of his functions is to assess if an initiated change may impact the approved regulatory documentation, and if the approval from HA is required before change implementation. The complexity of technical change assessment increases significantly in case a pharmaceutical product is globally registered: for such products the technical regulatory manager should consider not only the content of the approved dossier, but also a variety of country-specific and evolving regulations. Change assessment becomes even more challenging when the product in scope is a biotechnological product.
The scope of this thesis is to describe three possible options a pharmaceutical company could implement to correctly assess technical changes impacting the module 3 of worldwide approved pharmaceutical products. The ultimate goal of each of the presented options is to minimize the risk of performing a wrong change assessment, which could generate incompliances of the approved dossier against the country-specific regulation and against the internal documentation describing the manufacturing and control of pharmaceutical products.
The three options described in this work consist in performing technical change assessment at the company headquarters (centralized), at the company affiliate level (decentralized), or by leveraging the support of regional offices which function as connection between headquarters and local affiliates (liaised).
These options are presented and evaluated against the ultimate goal of change assessment, which is to perform an evaluation in compliance to each post-approval regulation where a given product is registered and, at the same time, that allows the company to define a timely-mannered regulatory filing strategy.
Pages: 52         Annexes: -