Continuous manufacturing (CM) has been a goal for the pharmaceutical industry for several years. While small molecule drug substances and drug products have achieved this in many cases, biologics are behind the global implementation of CM because of their more complex manufacturing processes. However, the regulatory agency members of the International Committee for Harmonization (ICH) now have enough experience in the registration,...
Regulatory Governance
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Industry feedback on ICH harmonized guideline: Continuous manufacturing of drug substances and drug products Q13 draft version
Feb 2022 | Deliverable, Deliverables Report, Feedback to agency, Regulatory, Regulatory Governance
A comprehensive response to ICH Continuous manufacturing of drug substances and drug products Q13 draft version. The BioPhorum team overall think the draft reads well and believes the concepts and ideas are aligned with BioPhorum thinking on continuous manufacturing for biologic drug substance and drug product.
The Power of Industry Collaboration: Driving Harmonization of Regulatory Requirements
Mar 2021 | Cell & Gene Therapy, COVID 19, Development Group, Drug Substance, Fill Finish, Information Technology, MedTech, News, Regulatory, Supply Partner, Technology Roadmapping
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...
BioPhorum’s common industry voice: driving regulatory change at CASSS WCBP 2020
Mar 2020 | Drug Substance, News, Regulatory
As regulatory complexity and scrutiny continue to grow, collaborative industry bodies are, without doubt, the most effective way for industry to determine how to meet regulatory guidance through ‘strength in numbers’ using a ‘common voice’. This is at the core of BioPhorum’s approach.
Russian release – how to manage the risks of new analytical testing in Russia
Mar 2020 | Drug Substance, News, Regulatory
The Russian Federal Service for Surveillance in Healthcare currently mandates in-country testing for all batches of biologicals imported into its market. However, later this year, a new regulation will change the testing regimen. This will move from testing all batches (although only tests that are deemed ‘simple’) to testing the first batches of biological products that are imported and then on an annual basis – but performing all tests in the...