is quality assurance director, Merck & Co. Inc., Rahway, NJ, USA.

Peter J. Mlynarczyk

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Submitted: January 9, 2024.
Accepted: February 6, 2024.

This study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases. More and more countries acknowledge the limited value of in-country testing compared to the benefit of full or partial testing waivers. Analyzing the changing testing requirements, the authors find that a predominant trend is waiver schemes based on unilateral reliance on reference countries with a mature regulatory system.

In 2015, an overview of in-country quality control (QC) testing requirements for pharmaceutical products—the term “pharmaceutical product”, or simply “product”, will be used in this article to refer to small molecules, biologicals, and/or vaccines—and data on the efficiency of this practice were published by Garbe 

 (1). Findings from this study on import testing, based on data collected from multinational pharmaceutical companies, suggested that import testing does not add significant benefits to the quality or safety of drugs, provided that the products are uninterruptedly controlled according to the globally harmonized manufacturing and distribution standards. The authors, therefore, recommended establishing more exemptions from import testing, subject to well-defined conditions, and that waiver procedures are applied where a company has demonstrated appropriate controls of manufacturing and distribution processes.

This article reviews changes in in-country testing requirements since this key publication in 2015, summarizes the evolution in the field of in-country testing, and analyzes current trends.

Two categories of in-country testing form part of the considerations of the review:

 which is performed in conjunction with the product registration.

 which is the repeated QC testing of pharmaceutical products entering a country, including lot release testing of vaccines and blood products.

The different categories of in-country testing and their impact are further described by Garbe 

Both categories of re-testing raise comparable challenges with regards to technical/supply/environmental issues, efficiency, and costs. One of the main impacts of in-country testing is delayed supply of products to patients. Import testing can cause drug shortage situations (1–5) while registration testing (initial market application) can cause long delays in patient access to new medicines (6), which can damage public health.

Several articles on in-country testing were published since 2015 (1–6). Therein, import testing was analyzed regarding its efficiency, the associated risks, challenges, issues, and costs. Supported by real data (1), a limited value of the procedure was concluded.

, is global quality manager and policy lead, F. Hoffmann‑La Roche Ltd., Pharma Global Technical Operations, Basel, Switzerland; 

is quality unit lead and technical director, Bristol Myers Squibb, São Paulo, Brazil; 

is director CMC Technical Advocacy and Policy, Merck Sharp and Dohme, LLC, Horsham, PA, USA;

 is director, Regulatory Intelligence, Pfizer Global Supply, New York, US; 

is chief pharmaceutical officer, Sanofi Vaccines, Lyon, France; 

is quality assurance director, Merck & Co. Inc., Rahway, NJ, USA; 

is scientific director, Johnson & Johnson Innovative Medicine, Leiden, The Netherlands; 

is head of External Affairs Europe, Amgen (Europe) GmbH, Rotkreuz, Switzerland; 

is global SME Quality Advocacy, Vaccines Global Quality, GSK, Wavre, Belgium.

*To whom all correspondence should be addressed

When referring to this article, please cite it as Garbe, J.H.O.; Conti, T.; McGoldrick, M.; et al. Reliance-Based Waivers Become the Predominant Trend in In-Country Testing of Pharmaceutical Products. 

Articles

This study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.