October’s Regulatory Focus: Linguistic review, advanced therapies in Asia-Pacific, and more

Feature ArticlesFeature Articles | 04 November 2021 | Citation

Feature articles during October included an in-depth look at the linguistic review process in Europe and  reviews of the regulatory pathways for herbal medicinal products, medical devices, and supplements in the EU and for advanced therapies in the Asian-Pacific region. Also included was an article on the challenges of data integrity remediation in cGMP facilities.
Linguistic review and herbal product regulation
The linguistic review process for centrally authorized products within the EU and European Economic Area is important for maintaining accurate, consistent, and high-quality product information  documents. However, the diversity of languages in those jurisdictions presents challenges in fulfilling review requirements for marketing authorization. In The linguistic review process in the centralized procedure in the EU, Emma Yang describes the process and lists the specific documents required at each milestone. She provides additional context by detailing initial marketing authorizations and extensions, the types of postapproval variations, renewals and re-assessments, work sharing, periodic safety reports, and referrals.
EU regulation of medicinal products, medical devices, and food supplements: A comparative perspective, by Andrada Armasu, is the first of two articles on this topic. Armasu outlines the key regulatory models for herbal products and recent regulatory developments. Since the same plant substance could fall within two different types of products, it can be challenging to decide which requirements apply to it. The EU legal framework allows for these products to co-exist under different regulatory settings and with different requirements: manufacturers of herbal medicinal products must apply for marketing authorization or registration from a member state’s competent authority before a product can be placed on the market; medical devices are subject to a conformity assessment; and food supplement manufacturers may be subject to a notification requirement. An additional article on this subject will be published in November and will address quality, the strength of evidence supporting the safety and efficacy, and postmarketing surveillance requirements, across the three product lines.
Advanced therapies and data integrity remediation
The rapid expansion of research and development in advanced therapies in some Asian-Pacific countries has spurred establishment of regional regulatory frameworks to facilitate accelerated marketing authorizations. In The regulatory landscape of advanced therapies in Asia-Pacific, Ellen Sem, Vicky Han, and Annetta C. Beauregard note there have been more early approvals for advanced therapies with the introduction of those regulatory frameworks and many multinational pharmaceutical companies are leveraging them to bring innovative medicines into the region. The article provides an overview of frameworks in Australia, China, Hong Kong, Japan, Malaysia, Singapore, and South Korea, where regulators have adopted a risk-based approach and expedited pathways in the regulation and evaluation of new products. In particular, China’s National Medical Products Administration has taken an active role in the international harmonization efforts and has submitted proposals to the International Council for Harmonisation on cell and gene therapy products.
Data integrity remediation is a critical activity for compliance with good manufacturing practice (GMP) and data integrity requirements. In recent years, regulatory agencies have identified several data integrity gaps with GMP and have issued guidance to help organizations circumvent those gaps. However, some manufacturing facilities may struggle to comply with guidance requirements because of outdated systems, limited resources, and/or high costs, note Loganathan Kumarasamy and Poorani Karunanidhi in Data integrity remediation and cGMP facilities. They outline the remediation process, from reviewing and assessing existing data, through identifying the gaps, assessing risks, creating a plan, and setting up and validating technical controls. The final remediation stages include implementing procedural controls, reviewing residual risks, and establishing ongoing risk monitoring or periodic review processes. Also presented are practical solutions for some of the challenges current GMP facilities have to address, such as system heterogeneity, technical limitations, increased personnel responsibility, and complex data flow structures. Two case studies provide useful examples of real-world challenges and solutions in data integrity remediation.
Citation Matthews R. October’s Regulatory Focus: Linguistic review, advanced therapies in Asia-Pacific, and more. Regulatory Focus. Published online 4 November 2021. https://www.raps.org/news-and-articles/news-articles/2021/11/octobers-regulatory-focus-linguistic-review-advanc

Upcoming in Regulatory Focus
What’s coming in November?
Articles during November will examine Global development for pediatric products. Look for this topic and more throughout November at Regulatory Focus.
And December?
For the December issue, Regulatory Focus will cover APL and the role of social media. The submission due date for articles has been extended to 21 November 2021. To contribute, email rmatthews@raps.org.
Call for articles
January 2022
The January 2022 issue of Regulatory Focus will cover Leadership in Regulatory Affairs. The submission due date for articles is 1 December 2021. To contribute, email rmatthews@raps.org.
Also see 2022 Editorial Calendar and Guidelines for Authors.        
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The latest issue, focusing on quality and compliance, is now available. Topics through 2022 will be:
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  • Software as a medical device (March 2022)
  • Regulatory history (June 2022)
  • Strategy in regulatory affairs (September 2022)
Previous issues of RF Quarterly  
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