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Editorial


Reflections on 2015 Regulatory Bioanalysis – regulation applications and deficiency letters


Keywords: matrix effect • method robustness • back-conversion • special population matrix • sample handling stability


The Contract Research Organizations (CROs) performing clinical trials based in Canada regularly work with many agencies. Worldwide Sponsors perform their clinical trials in Canada since it provides an inexpen- sive means by which to conduct their trials in a well-located site, and to gather results of known high quality. Moreover, since 2010, the Standards Council of Canada issues a GLP Certification that is internationally rec- ognised for nonclinical studies [1]. For many years, agencies such as the Euro-


pean Medical Agency (EMA), the US FDA, Health Canada and ANVISA (National Health Surveillance Agency, Brazil) have tried to harmonize their guidances and require- ments, and some of them proclaim to be harmonized. However, based on the multiple agencies audits that we have, we can easily see that small differences persist between the ways the guidances and requirements are applied. Many other guidances or regulations must be followed, such as the PMDA (Pharmaceuticals and Medical Devices Agency, Japan), MHRA (Medicines and Health products Regulatory Agency, UK) and TGA (Therapeutic Goods Administration, Australia) guidances. And what about the new GCLP defined by the World Health Organization (WHO)? The CROs must make sure they are aware of all the nuances in these regulations. The CROs must adapt their processes


according to the variation in the regulations. Moreover, two decades ago, the clinical tri- als performed for the submission of a generic medication were performed with the specific


10.4155/bio.16.5 © 2016 Future Science Ltd


reference product used where the medica- tion was to be approved. Less than 10 years ago, by opening the submission approval to the studies using a reference product already approved in other countries, the agencies have allowed the Sponsors to submit these clinical trials performed with other refer- ence products to cover applications in many countries. This is fortunate from an ethics point of view since it decreases the number of trials to be done. However, this allows, by the same fact, the submission of a same study in different countries using different regulations. Consequently, this pushed the CROs to adapt their processes to be compli- ant to many regulations. The standard oper- ating procedures (SOPs) should be adapted to many regulations in order to decrease the number of potential requests for additional information, such as the deficiency letters from FDA, EMA and ANVISA and the Clarifax from Health Canada.


Deficiency letters In this scientific world where the agency requirements are not only managed via guidances, but also by deficiency letters and audits, the CROs performing more and more studies with various/different agency requirements will receive more deficiency let- ters and need to find a way to answer them appropriately. Some examples of deficiencies can be dis-


cussed more deeply. Health Canada very recently requested to have the stability test- ing (bench-top, freeze–thaw, and long-term


Bioanalysis (2016) ISSN 1757-6180 part of


Ann Lévesque Former Senior Director at inVentiv Health Clinical, Québec, Canada


Sylvain Lachance Author for correspondence: inVentiv Health clinical, Québec, Canada sylvain.lachance@inventivhealth.com


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