Implementing the New GCP R3 Guidelines.

Authored byย Carmel Dafna

The updated ICH E6 R3 introduces key improvements from Version 2. Here are fundamental changes, focusing on how they directly impact the sponsor role:


Increased focus on Sponsor Oversight:
The update focuses on the responsibility of the sponsors to have a greater level of oversight. ICH E6 Version 3 emphasizes a more robust and proactive approach to ensure that the sponsors will play a critical role in protecting the participant’s safety and the integrity of clinical trials. This includes increasing the highlight on risk management and quality management systems.
 
Enhanced Sponsor Quality Assurance:
Version 3 emphasizes a proactive approach to quality management for sponsors and suggests tools and strategies to ensure the highest standards of data integrity, compliance, and overall trial success. This includes recommendations for sponsors to adopt Quality Management Systems, indicating that Sponsor Quality Assurance is adapting and evolving with the clinical research.
 
Risk-Based Monitoring Integration:
Significant change, allowing sponsors to evaluate how to allocate resources where they are most needed. This ensures sponsors can cultivate a more dynamic and responsive approach to managing study conduct and identifying risks.
 
Data Integrity and Security:
With an increased focus on data integrity and security, sponsors should be able to protect sensitive information throughout the trial. This not only addresses compliance concerns but also improves the reliability of the data generated.
 
Continuous Improvement Mindset:
ICH E6 Version 3 asks for continuous improvement from sponsors, expecting them to proactively assess and improve their processes to ensure that sponsors will optimize trial conduct and outcomes.

If you have any questions or need further assistance, please feel free to reach out to us at https://adres.bio/contact-us.

Unraveling the Intricacies of PRIME: Your Pathway to Accelerated Medicine Approval

Authored by Dr. Liron Gibbs-Bar

Embarking on the journey of bringing a new medicinal product to the market is no small feat. The road is long and filled with regulatory hurdles, especially when aiming to meet the high standards required for regulatory approval and market access. However, there’s a beacon of hope for applicants, particularly those in the academic sector and small to medium-sized enterprises (SMEs): the PRIME scheme by the European Medicines Agency (EMA).

Launched in 2016, the PRIority MEdicines (PRIME) scheme represents a pivotal shift in the EMA’s approach to medicinal regulation. Its primary goal is straightforward yet ambitious: to offer continuous scientific and regulatory guidance, coupled with an accelerated assessment process for new medicines that target unmet medical needs and hold significant public interest.

For researchers and companies working on groundbreaking treatments, PRIME offers a unique opportunity. Early Entry PRIME status can be a game-changer, especially for SMEs and academic applicants. This status is granted when proof of principle is demonstrated, opening doors to invaluable guidance from regulators early in the development process.

The EMA’s recent revision to the PRIME guidelines introduces several key features to enhance the scheme’s effectiveness:

  1. Pre-submission meetings to assist applicants in planning their PRIME application.
  2. Expedited follow-up scientific advice with shortened timelines, providing quicker access to essential guidance.
  3. A submission readiness meeting about a year before the marketing authorization application (MAA) filing date, offering a platform to discuss the development status and readiness of the marketing application dossier.
  4. A revamped approach involving the submission and maintenance of a regulatory roadmap and product development tracker, taking the place of the PRIME annual update.

These enhancements are designed to deepen knowledge, and support accelerated assessments, significantly benefiting those navigating the complex waters of medicinal product development.

At ADRES, we understand the intricacies of the regulatory landscape, including the PRIME designation. Our team has extensive regulatory submissions experience, catering to SME and non-SME companies.ย 

We recognize the challenges and opportunities of seeking PRIME status and are equipped to guide you every step of the way.

Navigating the PRIME pathway can be daunting, but with proper support and guidance, it’s a journey you can embark on with confidence. 

You’ve got this!

If you have any questions or need further assistance, please feel free to reach out to us at https://adres.bio/contact-us.

๐€๐ซ๐ž ๐ฒ๐จ๐ฎ ๐ฌ๐ญ๐ซ๐ฎ๐ ๐ ๐ฅ๐ข๐ง๐  ๐ฐ๐ข๐ญ๐ก ๐ญ๐ก๐ž ๐œ๐จ๐ฆ๐ฉ๐ฅ๐ž๐ฑ ๐ซ๐ž๐ ๐ฎ๐ฅ๐š๐ญ๐ข๐จ๐ง๐ฌ ๐ฌ๐ž๐ญ ๐›๐ฒ ๐ญ๐ก๐ž ๐…๐ƒ๐€ ๐š๐ง๐ ๐„๐Œ๐€?

ADRES Webinar on Pre-Approval Inspection Readiness

๐“๐ก๐ข๐ฌ ๐ฐ๐ž๐›๐ข๐ง๐š๐ซ ๐Ÿ๐จ๐œ๐ฎ๐ฌ ๐จ๐ง ๐ข๐ง๐ฌ๐ฉ๐ž๐œ๐ญ๐ข๐จ๐ง ๐ซ๐ž๐š๐๐ข๐ง๐ž๐ฌ๐ฌ, providing comprehensive insights into the necessary activities and best practices to face regulatory inspections confidently.

This webinar caters explicitly to companies involved in the clinical development of Pharmaceuticals, biologics, and combination products.

We promise to demystify the process and equip you with actionable strategies to transform uncertainty into confidence.

Whether it’s understanding the implications of a Voluntary Action Indicated (VAI) status from a key subcontractor or simply refining your readiness checklist, we’ve got you covered.

If you have any questions or need further assistance, please feel free to reach out to us at https://adres.bio/contact-us.

Join our YouTube channel, where you can find our original videos, with relevant information.


Empowering Rare Disease Treatment Development

The Financial Incentives of Orphan Drug Designation and Expert Regulatory Consulting Support

Companies developing treatments for rare diseases can actually gain valuable financial incentives from an โ€˜orphan drug designation.โ€™

Such a designation not only provides partial tax credit for clinical trial expenditures and waived user fees (e.g. for scientific advice) โ€“ but also eligibility for 7/10 years of marketing exclusivity in the US/EU, respectively.

Additionally, according to a recent study (- https://ojrd.biomedcentral.com/articles/10.1186/s13023-017-0665-6 LINK TO THE study), the โ€˜orphanโ€™ designation appears to be successful at generating positive value for companies, as seen by the positive and significant average increases in stock prices.

The expert regulatory consulting team at ADRES has extensive experience in obtaining orphan drug status, in both the US and EU.

We can advise and prepare such applications for a variety of technologies and indications โ€“ including for challenging circumstances in which a strong scientific rationale is required.

If you’re interested in learning more about rare diseases, including how to determine if a drug is eligible for Orphan Drug Designation, the process for submitting to OMPD, and how to justify the investment needed for drug development, then downloading the file is definitely recommended. It contains valuable information on all of these topics and more.

Download the file

GMP Annex 1 โ€“ Final Revision

๐“๐ก๐ž ๐„๐ฎ๐ซ๐จ๐ฉ๐ž๐š๐ง ๐”๐ง๐ข๐จ๐ง ๐ซ๐ž๐œ๐ž๐ง๐ญ๐ฅ๐ฒ ๐ข๐ฌ๐ฌ๐ฎ๐ž๐ ๐ญ๐ก๐ž ๐Ÿ๐ข๐ง๐š๐ฅ ๐ซ๐ž๐ฏ๐ข๐ฌ๐ข๐จ๐ง ๐จ๐Ÿ ๐†๐Œ๐ ๐€๐ง๐ง๐ž๐ฑ 1: ๐Œ๐š๐ง๐ฎ๐Ÿ๐š๐œ๐ญ๐ฎ๐ซ๐ž ๐จ๐Ÿ ๐’๐ญ๐ž๐ซ๐ข๐ฅ๐ž ๐Œ๐ž๐๐ข๐œ๐ข๐ง๐š๐ฅ ๐๐ซ๐จ๐๐ฎ๐œ๐ญ๐ฌ, ๐•๐จ๐ฅ. 4 ๐Ÿ๐จ๐ซ 2022.

Many of the changes are more stringent than in previous versions. For example:

โ€ข Separate change rooms are required for entering and leaving production areas if the Contamination Control Strategy (CCS) indicates the risk of contamination is high

โ€ข For cleanroom qualification and EM, all grades are required to measure the total particles equal to or greater 0.5 and 5 ยตm/m3, with instructions to consider 5ยตm particles measurements where limits are not specified

โ€ข For Interventions, all non-qualified interventions should be recorded in the batch record, authorized by the quality unit, and assessed.

We thought the most interesting change required the bioburden samples be taken prior to the first filter if a redundant filtration setup is used.

These are just a few of the changes to the annex. To learn how these and other updates could impact your operations, download our GMP Annex 1 guidelines and reach out.


Skip to content