Post approval


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What’s changing in the Chinese CMC regulatory environment? 

China is a commercial market with enormous potential for the biopharmaceutical industry but is transitioning from a national regulatory environment to one that is harmonized with the global industry, albeit with some local specifics and complexities. BioPhorum’s Post-Approval Strategy Team has been navigating this new Chinese regulatory environment through its many recent changes. To capture its learnings, the team has produced a poster titled...

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What is changing in China CMC regulatory?

BioPhorum’s Post-Approval Strategy Team has produced a poster titled What is changing in China CMC Regulatory? It refers to a wide range of changes in areas such as pharmacopeia, e.g., more convergent monographs in CHP 2020 than any other version of the Chinese Pharmacopeia. It also talks about changes in submissions, including excipients and primary packaging materials need to be registered on the Chinese Drug Master File platform before use in products. It can be used by BioPhorum member organizations, displayed in a CMC regulatory office, used at CMC meetings, and shared with colleagues outside the regulatory function.

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Driving industry consensus on the EU’s Medical Devices regulation

The EU Medical Device Regulation (MDR) Article 117 became legally binding and mandatory in May 2021, but there is no clear industry consensus regarding its application to integral drug delivery devices. The regulation is particularly unclear in the case of a device constituent part being classified as an invasive device, and whether all drug product contacting components must conform to the requirements for invasive components. There are also...

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Implementation of Article 117 of European Union Medical Devices Regulation (EU MDR) General Safety and Performance Requirements: a position paper

The EU MDR Article 117 became legally binding and mandatory in May 2021, but there is no clear industry consensus regarding its application to integral drug delivery devices. The regulation is particularly unclear in the case of a device constituent part being classified as an invasive device, and whether all drug product contacting components must conform to the requirements for invasive components. There are also ambiguities regarding requirements such as notified body opinion and human factor study requirements. This paper presents an industry position statement and illustrates the concerns.

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BioPhorum’s expert feedback on the FDA’s ICH Q12 guideline

The globalization of the supply chain and market for medicinal products are complex areas. They have resulted in a growing number of different procedures, rules and country by country regulations that must be followed whenever post-approval changes to chemistry, manufacturing and controls (CMC) are proposed for various reasons. These regulations can stifle innovation and process improvements that ultimately benefit the patients. ICH...

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Industry feedback on ICH Q12: implementation considerations for FDA-regulated products

The aim of ICH Q12 is clearly stated as a framework to facilitate the management of post-approval CMC changes. This document in the industry response to an agency consultation on draft guidance on ICH Q12. The biopharmaceutical industry through these comments commends the agency on leading the way to the implementation of ICH Q12. The BioPhorum comments are heavily influenced by the principle of simplification, which is why our views sometimes differ from the draft guideline.

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The Power of Industry Collaboration: Driving Harmonization of Regulatory Requirements

Driving the harmonization of regulatory requirements – one country at a time  Regulations play a significant role in assessing marketing authorizations for drug products that are submitted for approval. Yet, regulatory agencies often differ in their degrees of harmonization. This has created an environment of divergence, in which countries each have unique standards, requirements, submissions and review processes.  The potential...

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Post-Approval Strategies: Risk-based approach for analytical comparability and comparability protocols

Chemistry, manufacturing, and control post approval changes are an intrinsic part of the life cycle of pharmaceutical products. In this paper, the authors examined the potential impact of such changes on the product quality, safety, and efficacy of biologics. Comparability studies and more specifically analytical comparability are introduced as one of the tools that can support both biomanufacturers and health agencies in ensuring that patient safety and product safety and efficacy is maintained through the proposed changes. Together with a scientific risk-based review approach based on product and process knowledge and the definition of acceptance criteria that will ensure that the product is “essentially similar”, what constitutes a holistic comparability study is detailed. ICH Guidelines principles and definitions are used throughout the paper to aid the reader with other appropriate references. Finally, two case studies are presented: change to the manufacturing facility of the drug substance, and change to the manufacturing process of a drug substance intermediate and manufacturing facility.

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China: Registration of raw materials entering the composition or presentation of biopharmaceuticals

Since 2017, it has been mandatory for suppliers of APIs, excipients and packaging materials to register their material in China on the DMF registration platform. While many agencies ask for details of a component’s quality and its impact on products, the Chinese requirements for ‘high risk’ materials, such as those used in biopharmaceuticals, also ask for historical information that is typically proprietary which many suppliers are reluctant to share. This paper summarizes the requirements for raw materials in other ICH countries and compares these to the Chinese approach. The paper also lists all of the details needed for the Chinese registration of biopharmaceutical products’ raw materials in a single place, to help suppliers register their products into this vast market.

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Slicing years off change implementation

Slicing years off change implementation Harmonizing post-approval change regulations As the first regulatory authority in Latin America to gain full membership of the International Council for Harmonization (ICH), the Brazilian Health Regulatory Agency (Anvisa) asked BioPhorum to support it in its review of national regulations relating to post-approval change (PAC) submissions. Brazil’s regulations, RDC50 about the stability data required to...

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