Last week’s round-up, 25-29 November 2019

By Stephanie Allampalli and Marthese Mifsud   EMA to Implement Ombudsman’s Recommendations on Avoiding Bias 29 November 2019 The EMA has announced that it will be following the recommendations of EU ombudsman Emily O’Reilly, following an inquiry regarding the perception of bias in MA assessments. The inquiry was carried out due to concerns that interactions […]

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Last week’s round-up, 18-22 November 2019

By Stephanie Allampalli and Marthese Mifsud CHMP’s Position on NDMA in Ranitidine 21 November 2019 The CHMP has held discussions on the course of action to be taken within the EU over the presence of the carcinogenic impurity NDMA in some batches of ranitidine medicines. In order to assess the potential root causes and their […]

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Last week’s round-up, 11 -15 November 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   ICH Survey Shows Wide Adoption of Guidelines Among Regulators, Industry 15 November 2019 A recent survey shows wide adoption of ICH guidelines across regulators and industry. The survey collected responses from 32 pharmaceutical companies who provided information on 15 regulatory authorities, which ranged between ICH founding members, newcomers […]

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Last week’s round-up, 04 – 08 November 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   IPEC Continues to Encourage China to Align with Global Science-Based Excipient Standards 08 November 2019 Global excipient manufacturers are continuing to push the Chinese Pharmacopoeia to align with other pharmacopoeias. Manufacturers are working through the International Pharmaceutical Excipients Council (IPEC), which is closely monitoring changes to requirements for […]

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keyboard and monitors

Last week’s round-up, 28 October 2019 – 01 November 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   OGD Explains How it Reviews and Conducts Pre-ANDA Meetings 01 November 2019 The FDA’s Office of Generic Drugs (OGD) has explained how it evaluates and conducts meetings under its pre-abbreviated new drug application (ANDA) program. To this end, the OGD has issued a manual of policies and procedures, […]

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BREXIT

Last week’s round-up, 21 – 25 October 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   EMA to Cease Printing and Dispatching of CPPs During Relocation to Permanent Building 25 Oct 2019 The EMA will temporarily cease printing and dispatching of Certificates of Pharmaceutical Products (CPPs) during relocation to its permanent building. This temporary suspension will take place between 13th December 2019 and 18th […]

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pills

Last week’s round-up, 14 – 18 October 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   Updated product-specific bioequivalence guidance 18 Oct 2019 The EMA has finalised product-specific bioequivalence guidance for seven drug substances. The substances affected are alectinib, apixaban, cabozantinib, colchicine, ezetimibe, gefitinib, and palbociclib. All guidances were adopted on 15 October 2019. Those for apixaban and gefitinib will become legally effective on […]

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Last week’s round-up, 07 – 11 October 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   ICH Reverts to Previous Version of Guideline on Residual Solvents 11 Oct 2019 The ICH has reverted to its previous version of the guideline on residual solvents. This change affects the Permissible Daily Exposure (PDE) for ethylene glycol. In October 2018, an error correction procedure was launched to […]

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Last week’s round-up, 30 September – 04 October 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   Delays in treatment of requests for revision and renewal of CEPs 03 Oct 2019 The EDQM has communicated that it is currently experiencing some difficulty in achieving the assessment times for revisions and renewals of CEP applications. The delay is currently about 5 weeks and the EDQM has […]

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Last week’s round-up, 23-27 September 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   EMA advises companies on steps to take to avoid nitrosamines in human medicines 27 Sep 2019 All EU marketing authorisation holders of medicinal products containing chemically synthesized APIs need to review their medicines for the possible presence of nitrosamines within the next six months. The EMA is sending a notice to […]

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