Must-know updates for the new risk-based ICH GCP Guideline

A new addendum to the ICH Good Clinical Practice (GCP) Guideline carries broad implications for sponsors, CROs, and investigators. The guideline, now known as ICH E6 (R2), was drafted in response to advances in technology within clinical trials (e.g. electronic data recording and reporting, centralized monitoring) since E6 (R1) was prepared. The new addendum aims to “encourage implementation of improved and more efficient approaches to clinical design, conduct, oversight, recording, and reporting while continuing to ensure human subject protection and reliability of trial results.”

Why does this matter for sponsors? The addendum’s changes could transform how clinical monitoring and trial management are conducted by “requiring the adoption of centralized, quality risk management (QRM) throughout the trial lifecycle.” Sponsors must satisfy the principles of a quality management system (QMS) based on the risks and potential errors in critical data and processes. To address identified significant non-compliance, the guidance provides three principles for sponsors to follow: significant non-compliance identification, root cause analysis, and custom made corrective and preventative action. Moving forward, sponsors will need to maintain oversight of tasks delegated to CROs, placing responsibility on the CRO to maintain effective systems to track data and tasks during clinical research.

The guidance also introduces a new framework to encourage sponsors to adopt innovative technologies. An overview of the new addendum describes the three main concerns addressed by this new framework. First, the framework specifies requirements for the validity, longevity, and fidelity of trial data as sponsors transition from physical to digital records and update or change between digital systems. Second, it encourages “standard processes to avoid situations where real-time data aggregation and visualization may inadvertently influence trial outcomes inappropriately early in the trial process.” Third, the framework expands upon the need for control by investigators of their generated data and documents.

Risk-based quality management, risk-based monitoring, and CRO oversight sum up the three main roles and responsibilities outlined in the addendum. Reviewing and understanding the full addendum will be vital in your preparation for the upcoming changes. Please contact us at Pearl Pathways to discuss the needs of your clinical research.

Changes made to GCP guidelines

Check out this article by Dr. Colin Wilsher about the newly released changes to International Good Clinical Practice (GCP). It’s important for the industry to follow the same quality standards for clinical trials and to understand the changes that have been made. ICH predicts that the final guidelines will be complete in November 2016.

For more information from the Research Quality Association (RQA) website, click here.

Health Canada tries to harmonize regulatory support

In 2011, the United States and Canada came together to create the US-Canada Regulatory Cooperation Council (RCC) in order to reduce economic barriers and increase regulatory support between the two countries.

Four years later, Health Canada and FDA are making efforts to continue to harmonize how both countries regulate drugs, medical devices and biological products. The two agencies are currently working on plans to synchronize the three disciplines and have already completed one plan (See their most recent plan). The two partnering countries hope their efforts increase commerce between the US and Canada, as well as improve the health care industry.

Click here to read more on the background of Health Canada and its future efforts. Need help with a Canadian regulatory filing? We can help. Contact us at .

FDA proposing six new rules in the next year

The US Food and Drug Administration (FDA) has significant changes in regulation planned throughout the next year, as shared by Alexander Gaffney of The article highlights six major proposals, five of which fall under the Drug Quality and Security Act (DQSA) of 2013. The following is a brief description of each rule, in order of anticipated or prior proposal release date:

  • Proposal granting FDA authority to destroy low-value drugs that are refused admission into the U.S. (May 6, 2014).
  • Modification of the list of drug products that may not be compounded as a result of the product’s removal from the market, due to safety and efficacy concerns (May 2014).
  • Rules regarding human drug compounding conditions within 503A and 503B facilities (October 2014).
  • Rule outlining the minimum requirements for good manufacturing practices (GMP) at outsourcing facilities (November 2014).
  • Revision of the current requirements regarding annual reports submitted to investigational new drug applications (INDs) to create consistency with the requirements endorsed by the International Conference on Harmonization (ICH). (March 2015).
  • Final rule establishing national standards for licensing prescription drug wholesale distributors and third party logistics providers (November 2015).

To read the full article, click here.

USP and ICH butting heads on elemental impurity standards

Zachary Brennan of shares that both the U.S. Pharmacopeia (USP) and the ICH are currently updating elemental impurity standards and there are some differences between the two. This could cause costly reformations in the future for companies that must meet these guidelines. Other organizations such as the EU or the Japanese Pharmacopeia declared that they would wait for the ICH to finish before they developed their own standards. David Schoneker, chairman of the Coalition for the Rational Implementation of USP Elemental Impurity Requirements, whom found the situation puzzling, added “There isn’t an imminent safety problem. We want better controls on metals, and we just want better ideas that don’t create waste.” Why do you think the USP went against reasonable time standards to develop impurity standards? Read the full article here.

EMA Attempts To Support Continuous Process Verification With New Guidelines

The European Medicines Agency (EMA) has released draft guidelines regarding continuous process verification (CPV) to bring its policies in line with ICH Q8, Q9, and Q10.  The goal is to gain information a manufacturer can use to make adjustments during production to maintain drug quality, “If appropriate, the product may benefit from a defined period of enhanced sampling and monitoring to help increase process understanding as part of continuous improvement,” the EMA wrote.  While the EMA has acknowledged the benefits CPV can provide, it also says a hybrid approach using traditional process validation is also an option.  To read more, click here.  To view the EMA’s draft guideline, click here.