The Regulatory Times

April 2018

Your monthly round-up of Life Sciences regulatory news from around the globe


Final Guidance for Industry

Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients; questions and answers

This guidance is the FDA issue of the Q&A published by ICH in June 2015.  ICH Q7 is intended to assist applicants with respect to good manufacturing practice (GMP) for the active pharmaceutical ingredients (APIs) to ensure that APIs meet the appropriate quality and purity characteristics.

FDA link:
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ICH link:
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Guidance for Industry

Liposome Drug products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labelling Documentation

This guidance is intended to assist applicants preparing to submit to FDA investigational new drug application (IND) and abbreviated new drug applications (ANDAs) for a liposome drug products reviewed by the Center for Drug Evaluation and Research (CDER).

This guidance focus on the unique technical aspects of liposome drug products and does not provide recommendations on clinical efficacy and safety studies; nonclinical pharmacology/toxicology studies; or drug-lipid complexes.

For details please refer link provided below:
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Draft Guidance for Industry

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations

This guidance is intended to provide recommendations to industry on the development and manufacture of inhalation aerosols (also known as metered dose inhalers (or MDIs)) and inhalation powders (also known as dry powder inhalers (or DPIs)) intended for local or systemic effect.

This guidance does not discuss aqueous-based nasal spray drug product and inhalation solution, suspension and spray drug products or the manufacture of drug substances. However, some of the principles of this guidance may be applicable to nasal delivery products. Also, this guidance does not discuss considerations for when an MDI or DPI includes electronic components, software, or novel inhaler components that might affect the performance or reliability of the product.

For details please refer link provided below:
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Regulatory information – 1.7% increase of fees from 1 April 2018

Fees payable to the European Medicines Agency (EMA) by applicants and marketing-authorisation holders are increased by 1.7% since 1 April 2018 in line with the European Union (EU) inflation rate for the previous year.

Details of the new Fee levels (all types of procedure handled by the Agency, except for pharmacovigilance procedures) can be referred in Commission Regulation (EU) No 2018/471 amending Council Regulation (EC) No 297/95,  published on 28 March.

For Details, please refer below link :
EMA website

Redistribution of the UK centrally authorised product portfolio

The redistribution of the UK centrally authorised Committee for Advanced Therapies (CAT) and Committee for Medicinal Products for product (CAP) portfolio involves the reallocation of UK rapporteurs and co-rapporteurs from EMA’s Committee for Medicinal Products for Human Use (CHMP), Pharmacovigilance Risk Assessment Committee (PRAC)  and Committee for Medicinal Products for Veterinary Use (CVMP).

Allocation follows a  multifaceted approach for UK product portfolio within the Network, which takes into consideration the results of the surveys, the expertise within the Network and workload for each medicinal product.

For Details, please refer below link :
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MDh position paper on the use of QR codes to provide information about the medicinal product

The QR code (abbreviated from Quick Response Code) is a two-dimensional bar code that is used to provide easy access by patients and/or Health Care Professionals to drug information. The possibility of using these codes as a way for providing information, in a broad sense, on medicinal products is currently being considered not only by the Pharmaceutical Companies but also the National Competent Authorities (NCAs). QR codes and 2D barcodes in medicines packaging have been proposed to access web pages (either maintained by the industry or by NCAs) with information about the medicine, to provide batch number and expiration date to visually handicapped, for manufacturing processing and stock control or as the safety features included in the falsified medicines legislation. This paper only addresses the use of QR codes to access web pages with information about the medicinal products.

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Increasing oversight of API manufacturing through international collaboration

The European Medicines Agency (EMA) and its European and international partners have successfully created a framaework to build up  their interactions to improve the monitoring of active pharmaceutical ingredient (API) manufacturers worldwide, as highlighted in the International API inspection programme report for 2011-2016. Based on the conclusions of this report, the participating authorities recommend the continuation of this international collaboration on API Inspections.

This international collaboration involves EMA, several European Union national authorities (France, Denmark, Ireland, Italy, and the United Kingdom), the European Directorate for the Quality of Medicines (EDQM), the United States Food and Drug Administration (FDA), Australia’s Therapeutic Goods Administration (TGA), Health Canada, the Japanese Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), and the World Health Organization (WHO) to share information on good manufacturing practice (GMP) inspections of manufacturers of APIs that are located outside the participating countries.

For Details, please refer to the below link :
EMA website



Provisional approval pathway: prescription medicines – March 2018

Based on the preliminary clinical data, prescription medicines can be approved through a provisional pathway. It will provide access to certain promising new medicines where the benefit of early availability of the medicine outweighs the risk inherent in the fact that additional data are still required.

Registration will automatically lapse at the end of a specified period (maximum 6 years) unless sponsors are able to demonstrate that they have met the conditions imposed on the provisional registration.

Refer to below link for Details:
The Australian Government website

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