March Regulatory Update

Welcome to the March edition of our Regulatory Update! Our team has been committed?to keeping you informed on the regulatory and standard updates within the past two months.

GLC has been busy with a number of upcoming projects. From our Head of Clinical Operations Thomas Hong presenting his latest research at ARVO, and a webinar with our CEO Robert Lin, MBA and Taimei Technology discussing collaboration between China and Australia for Clinical Trials. If you would like to know more about upcoming activities from GLC make sure to get in contact with your local Business Development Manager to stay updated.

If you are interested in knowing more about how our team can support your drug or medical device development, including personalized consultations and optimal pathways for your clinical trial. Make sure to contact our team to discuss your options.?

Below is a summary of changes and updates that we have highlighted for clinical research.

General Interest

World's first Entire Eye Transplant?

World's First Entire Eye Transplant Declared a Medical Breakthrough : ScienceAlert

NZ - Privacy Commissioner to keep a close eye on Foodstuffs

Office of the Privacy Commissioner | Privacy Commissioner to keep a close eye on Foodstuffs North Island FRT trial

NZ - Gene editing treatment success

Northland patient with rare disorder cheers success of gene-editing treatment - NZ Herald

Australia

Regulatory Changes

Therapeutic Goods Regulation 1990.?

Latest amendment registered 01 Jan 2024 up to Therapeutic Goods Legislation Amendment (Vaping). Regulations 2023 and Registered 28 Nov 23 up to Therapeutic Goods Legislation (2023 measures No. 2) regulations 2023

Therapeutic Goods (Medical Devices) Regulations 2002.

Latest Amendments effective 01 Jan 24 and 28 Nov 23 incorporating amendments up to Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023

Customs (prohibited imports) regulations 1956.

Latest amendments:? 1) effective date 01 Jan 24 Incorporating amendments up to Customs Legislation Amendment (Vaping Goods) Regulations 2023. 2) effective date 13 Dec 23 - incorporating Customs Legislation Amendment (Prohibited Imports and Exports) Regulations 2023.

Special Access Scheme Guidance for Sponsors

Previous version 1.1 March 2023,?New version 1.2 November 2023

NATA Privacy Policy

Previous version July 2020, New version December 2023

NATA Procedures for accreditation

Previous version September 2023,?New Version January 2024

USA

General Interest

CDER researchers describe a high-fidelity computational model of the anterior eye for predicting the pharmacokinetics and pharmaco-dynamics of topically administered ophthalmic drug products.

Learn more here.

FDA Guidance

January 2024 -?Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products | FDA

January 2024 -?Human Gene Therapy Products Incorporating Human Genome Editing | FDA

December 2023 -?Quality Considerations for Topical Ophthalmic Drug Products | FDA

December 2023 -?Rare Diseases: Considerations for the Development of Drugs and Biological Products | FDA

December 2023 -?Digital Health Technologies for Remote Data Acquisition in Clinical Investigations | FDA

December 2023 -?Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products | FDA

December 2023 -?Data Standards for Drug and Biological Product Submissions Containing Real-World Data | FDA

Draft Guidance Issued

December 2023 -?Potency Assurance for Cellular and Gene Therapy Products. For a high-level overview of this guidance document, please?view this recorded webinar.

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Collection of Race and Ethnicity Data in Clinical Trials | FDA

Upcoming Webinars (Free)

Enhancing Adoption of Innovative Clinical Trial Approaches - 2 days 19-20 March Enhancing Adoption of Innovative Clinical Trial Approaches

Recorded Webinars and training (free)

• 2023 NanoDay Symposium: Continuous Manufacturing of Nanomaterials
• BsUFA III Regulatory Science Pilot Program
• Use of Biomarkers for Diagnosing and Assessing Treatment Response in Noncirrhotic NASH Trials
• Advancing Generic Drug Development: Translating Science to Approval 2023
• Understanding FDA Inspections and Data
• OTC Monograph Reform: OMOR Format and Content & Electronic Submissions
• Using Bayesian Statistical Approaches to Advance our Ability to Evaluate Drug Products
• ClinicalTrials.gov – a Three-Part Series
• Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products
• Decentralized Clinical Trials (DCT) Draft Guidance

Project Socrates: Educational Opportunities

FDA Oncology offers free educational programs for anyone interested in regulatory science and drug development. Check out the?Project Socrates?web page for more information.?

Oncology Regulatory Science Online Lecture Series: Learn about INDs, Expedited Pathways, Clinical Trial Design, Statistics, Patient-Focused Drug Development, Real-World Evidence, and more!?

Project Livin’ Label: Listen to the “behind the scenes” discussions of the development and backstory of approved oncology drugs. All are free with CME credit offered by AACR.?

Oncology Fellowship Program Directors: If you are interested in having FDA Oncology speak at your program, reach out to us at [email protected].?

New Zealand

Regulation Changes

NZ Hazardous Substances and New Organisms (HSNO) Act 1996.?

previous version as at 05 Oct 2023,?new version as at 23 Dec 2023

Want more information about regulatory?requirement support?or information on how can advance your clinical trial? Contact our Business Development team for a confidential chat.

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