Previous Blogs

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By Bettine Boltres, PhD.

May 05, 2020

We are living in very unpredictable times. The virus SARS-CoV-2 is keeping the global pharmaceutical industry, including regulatory agencies, very busy. The whole industry is working together in the development of treatments and vaccines. The process of getting these treatments approved and to patients as quickly as possible requires the undivided attention of regulatory agencies, such as the FDA and EMA. As a result, the following deadlines have been extended for certain other requirements.

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By Lynn Yao

April 03, 2020

With the continuous progress in medical science and technology, drug evaluation criteria in China are also changing and improving. In the past, drug evaluation criteria did not require generic drugs to have the consistent quality and efficacy of innovator drugs; so some had a gap in efficacy. Since 2015, the National Medical Products Administration of China (NMPA), formerly the China Food and Drug Administration (CFDA), rolled out the Generic Quality and Efficacy Consistency Evaluation (GQEC) to improve the quality and efficacy of generic drugs. Generic drugs whose quality and efficacy are deemed equivalent to innovator drugs will enjoy preferential treatment in public hospitals and prescriptions.

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By Fran DeGrazio

January 17, 2020

Part 1 of this two part blog series, gave a high-level overview of the new ICH guideline Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.  In part 2 of this blog series, some of the key takeaways will be discussed in more detail.  Q12 is intended to help companies demonstrate increased product and process knowledge, and understand which post-approval changes will require a regulatory submission, as well as the level of reporting for each category.

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By Fran DeGrazio

January 14, 2020

ICH (International Council for Harmonization) recently adopted (1 Nov 2019) the guideline Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. This guideline includes two annexes and aims to “promote innovation and continued improvement in the pharmaceutical sector”.