This month the EMA released a “Reflection paper in the requirements for selection and justification of starting materials for the manufacture of chemical active substances”. It aims to clarify some of the expectations of EU competent authorities arising from the guidance found in ICH Q11 regarding the information to be submitted in marketing authorisation dossiers to justify the selection of starting materials.
On 21 October 2014, the FDA released the final version of its Guidance for Industry entitled „Circumstances that constitute delaying, limiting, or refusing a drug inspection”. Delaying, refusing, denying – FDA inspectors often see themselves confronted with cooperation problems. The guidance intends to clarify how the law under Section 707 of FDASIA (Food and Drug Administration Safety and Innovation Act) will be interpreted and put into practice by the FDA.
The ICH Steering Committee has endorsed the final concept paper Q12 “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management”. According to the ICH this new document shall provide guidance on a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the lifecycle of a product.
The World Health Organization (WHO) has published the revised draft of the Supplementary Guideline on Good Manufacturing Practices: Validation Appendix 7: Non-sterile Process Validation.
A new webpage has just been launched under the Certification of Suitability section of the website.
The application forms for requests for certificates of suitability (CEPs) have been updated.
Shortly before the next PIC/S Committee Meeting on 20-21 October 2014 in Paris, the Croatian Agency for Medicinal Products and Medical Devices (HALMED) applied for PIC/S membership.
The use of products with non-declared pharmacological activity or “other illegal medicines”, often from uncontrolled sources but also purchased from the legal market, is still a major problem within Europe.
From 10-11 September 2014, the second symposium on combating counterfeits and other illegal medicines took place at EDQM. Representatives from forensic and customs laboratories, national medicines and food authorities, enforcement groups and the European Commission were invited to shed light on the problem of falsification of medicines.
A comprehensive report of the last ICH meeting, which was held in Minneapolis, MN, USA, on 4-5 June 2014, is now available on the ICH website under the SC Reports page.
According to the Indian financial portal Business Standard and Money Control, the US FDA has started a surprise audit at the Halol Plant of SUN Pharma on Monday 8, 2014.
The Active Pharmaceutical Ingredients Committee, APIC, has recently published a comprehensive How to do Document regarding electronic Common Technical Documents. eCTD is a topic of increasing interest in the pharmaceutical environment. This guideline document focuses entirely on the first submission of an API dossier.
The European Commission has published the final version of the following revised chapters of the EU GMP Guide:
The deadline for implementation is 1 March 2015.
The EU’s decentralised procedure is being used as a model to accelerate the assessment of applications for generic medicines as part of the International Generic Drug Regulators PilotExternal link icon (IGDRP). The EU is leading an international pilot project through which, upon request from a generic pharmaceutical company, it will share the assessment reports generated as part of the decentralised procedure in real time with collaborating regulatory agencies outside the EU.
Following consultation within the TGA and with relevant stakeholders including Industry and consumer groups, a number of EU/ICH Guidelines have been adopted by the TGA, effective 1 August 2014.