Post-Approval Strategy

This workstream strives for harmonization of post-approval changes through direct interaction with regulatory agencies. The aim is to consolidate industry opinion and encourage the adoption of WHO guidelines and ICH principles.

Complexity is a burden

WHO and ICH guidelines are not universally adopted. The same change may be assigned a different change category and will require different data packages, depending on local regulations. Complexity is a burden, regulatory frameworks for PAC, often differ significantly from WHO guidelines, this results in:

  • Delays – For patient access, to market, or the manufacturer. Slow approval process and high cost to make change
  • Long lead time for change (from initiation to implementation)
  • Market fragmentation and parallel manufacture
  • Process improvements are delayed and discouraged
  • Principle of reliance between agencies cannot be applied

One voice

The team aims to be the consolidated opinion of the industry to trade bodies and regulatory authorities for changes post license by market and encourage the adoption of WHO guidelines and/or ICH principles for harmonization of regulatory requirements for PAS changes. This will accelerate the implementation of changes across the markets, reduce market fragmentation and supply chain complexity, reduce the number of different submissions or increase the efficiency of the submission process and increase the efficiency of the review and approval process by agencies resulting in improved compliance and fewer investigations related to raw materials.

Post-Approval Strategy deliverables


Post approval change management protocols for Latin America

31 July, 2023Webinar

How the industry has adapted to changes in China CMC regulatory

27 July, 2023Webinar

BioPhorum feedback on Columbia decree

19 January, 2023Member only

What is changing in China CMC regulatory?

10 June, 2022
7.51 MB

Webinar presentation PACMPS for LATAM

4 April, 2022
3.12 MB

An industry reflection on the application of the Russian Pharmacopeia to the registration of biologics

3 September, 2021
240.56 KB

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

2 November, 2020Link

Russia: In-country analytical testing of biopharmaceuticals, general recommendations

3 March, 2020
259.41 KB

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

15 January, 2020
238.74 KB

Post-Approval: General recommendations for harmonization of local regulations for post-approval submissions with WHO and ICH guidelines, example Brazil

11 March, 2019
181.52 KB

More related workstreams

Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.

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Advanced Therapy Medicinal Products

Advanced Therapy Medicinal Products support the quest for better and faster development of cell, gene and RNA therapies​ through connecting therapy developers, contract manufacturing, and testing organizations to gain an understanding and respond to the challenges faced by the advanced therapeutics industry.

Development Group

Development Group accelerates and improves the development process of biopharmaceutical medicines for the benefit of the patient. Replacing isolation with collaboration by providing a “safe” space where subject matter experts can work on sharing solutions and best practice on emerging industry trends, implementation of new technologies and common issues whilst ensuring their intellectual property and confidentiality is protected.

Drug Substance

Drug Substance advances excellence in drug substance manufacturing and testing, acting as an industry voice to accelerate technology adoption, implement post-approval change more rapidly and increase confidence in maintaining compliance.

Fill Finish

Fill Finish accelerates development and acceptance of sustainable world-class filling and packaging operations for drug product which meets the future needs of patients. Through innovative solutions resulting from the sharing of expertise, we can overcome common performance challenges and deliver on quality and regulatory compliance.

Information Technology

Information Technology accelerates digital maturity across the ​global pharmaceutical manufacturing industry.


BioPhorum Quality provides a dedicated, safe space for quality professionals from biomanufacturers and contract organizations to coalesce and enhance effective collaboration to address shared industry challenges.


Regulatory CMC brings leaders together who have a common goal – to improve access to medicines through innovation in the Regulatory ecosystem. It provides a dedicated space for strategic leadership and a coordinated industry voice, to move from divergence to convergence.

Supply Chain to Patient

Supply Chain to Patient transforms the performance of global pharmaceutical clinical and commercial outbound supply chains through industry collaboration by creating transparent patient-centric, resilient and agile E2E supply chains, that consistently deliver high-quality medicines ensuring an uninterrupted supply to patients.

Supply Partner

Supply Partner is a trusted advisory group and collaboration that is the engine for driving change across the global industry for all things relevant to the inbound supply chain. Addressing the challenges of complexity, resilience, cost, sustainability, and innovation.


Sustainability enables the industry’s transition to a low carbon, circular future – supporting members to improve patient health while respecting the planet. We activate multi-disciplinary teams drawn from our network to deliver environmental sustainability improvements across the value chain.

Technology Strategy

Technology Strategy acts as one voice of the industry to define strategy, accelerate technology transformation and support technology translation and adoption. With a purpose of enabling the future state of flexible, resilient, sustainable end-to-end biomanufacturing.

An industry perspective on understanding AAV capsid content variants
Needle On Yellow Background
An intercompany perspective on practical experiences of predicting, optimizing and analyzing high concentration biologic therapeutic formulations
The Drug Substance 2.0 Strategic Value Framework
Coloured dots on teal, next to vial
BioPhorum’s holistic approach to container closure integrity
Magnifying glass over a tablet all coloured blue
Digital Plant Maturity Model 3.0
Investigation Digital Workstreams
Peer to peer practical guidance on remote inspections and audits
The next step in building regulatory as a capability to enable strategic innovation across the BioPhorum community
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A visionary strategic framework for future patient-centric outbound biopharmaceutical supply chains
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A vision for the biopharmaceutical industry’s inbound supply chain
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BioPhorum environmental sustainability roadmap 2022
Technology Roadmap V 2.0
BioPhorum Technology Roadmapping roadmap vision 2.0


Documents including best practices, vision statements and peer reviewed papers to help you take value back to your business.


Discussing all aspects of the biopharmaceutical industry, from digitization and knowledge management to raw materials, supply chain, sustainability and more. Learn from the perspectives of those at the forefront of the industry.


BioPhorum Connect is our podcast series that keeps you up to date with the latest news and trends in the biopharmaceutical industry. From experienced professionals to thought leaders, these podcasts bring you the insights and perspectives of experts from around the world.


A variety of resources including design tools and user requirement specifications to help you improve and streamline your business processes.

Benchmarks and Surveys

Research conducted among the BioPhorum membership providing evidence to support change and identify best practice.

Browse all

Access a variety of free tools and papers and other resources designed to provide you with up-to-date information and insights to help you make informed decisions and maximize your success. Access our resources today and start making improving and streamlining your business processes.

Bioreactivity testing in single-use system biomanufacturing
Bioreactivity testing in single-use system biomanufacturing
Bioreactivity testing in single-use system biomanufacturing
Magnifying glass over a tablet all coloured blue
Digital Plant Maturity Model 3.0
Bioreactivity testing in single-use system biomanufacturing