The Regulatory Times

May 2019

Your monthly round-up of international Life Sciences regulatory news from the past month


Determining Whether To Submit an Abbreviated New Drug Application or a 505(b)(2) Application Guidance for Industry

This foundational guidance is intended to assist applicants in determining which abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act (FD&C) is appropriate for the submission of a marketing application to the FDA. Many potential drug product developers are not familiar with the different abbreviated approval pathways for drug products under this act — the abbreviated approval pathways described in section 505(j) and 505(b)(2) of the FD&C Act (21 U.S.C. 355(j) and 21 U.S.C. 355(b)(2), respectively) — or the types of data and information that are permitted to support approval under those pathways.

This guidance focuses on those applications that can be submitted as ANDAs under section 505(j) of the FD&C Act, petitioned ANDAs under section 505(j)(2)(C) of the FD&C Act, or NDAs pursuant to section 505(b)(2) of the FD&C Act. This guidance does not discuss standalone NDAs.

Submission through the appropriate Abbreviated approval pathway with Regulatory Considerations for ANDAs and 505(b)(2) Applications (Duplicates, Petitioned ANDAs, Bundling) and Scientific Considerations for ANDAs and 505(b)(2) Applications (Type of Studies, Data and Information Submitted in ANDAs, Active Ingredient Sameness Evaluation, Intentional Differences Between the Proposed Drug Product and the RLD and Other Differences) is discussed in the guidance.

Additionally the procedure for requesting assistance from FDA is also discussed in the guidance.

For details please refer to the PDF provided below:

PDF Download


Regulations on Common Regulatory Approaches for Allergen Products

The document is intended to provide principles and guidance for the regulation of medicinal allergen products with the aim to facilitate harmonisation throughout the EU. In this regard, applicable regulatory approaches for different classes of allergen products are discussed. This includes products of biological origin (allergen extracts derived from natural source materials) used for allergen immunotherapy (AIT), or for in vivo diagnosis of Type I (IgE)-mediated allergic diseases (e.g. skin prick test and nasal provocation test), and products intended for the diagnosis of Type IV cell-mediated allergies (e.g. patch test based on haptens).

The recommendations developed in this document generally apply to all allergen medicinal products as defined by Directive 2001/83/EC. As such, only medicinal products for human use intended to be placed on the market in Member States that are either prepared industrially or manufactured by a method involving an industrial process are concerned. It applies to all such products, including those for which a new MA is intended, or those that are already marketed with or without a MA.

Follow the link for full details:

HMA Website

Two Additional Countries to Benefit from EU-US Mutual Recognition Agreement for Inspections

On April 2019, the FDA confirmed the competence of two additional European Union Member States to carry out GMP inspections at a level equivalent to the United States (US). Bulgaria and Cyprus have been incorporated into the mutual recognition agreement between the EU and the US on 29 April 2019. The agreement mutually recognises inspections of manufacturing sites for human medicines conducted in the different territories and this means that the FDA will now rely on a total of 24 Member States whose inspection results can replace their own inspections

For details, please below to the link below:

EMA Website

European Commission Confirms Quality of South Korean Active Substances

The European Commission confirmed that the quality of active substances produced in the Republic of Korea are in line with EU standards. South Korea joins Australia, Brazil, Israel, Japan, Switzerland and the US as countries outside of the EU that have been established as manufacturing active substances in an EU-equivalent regulatory system with sufficient rules for manufacturing practices.

For more details, please refer to the PDF below:

PDF Download

Emerging Markets


Regulatory Fee Revision for Health Products (effective 2nd April 2019)

The HSA has introduced the fee revision for health products which has been implemented from 2 April 2019. This document is important for industry stakeholders which states that all renewal and retention system notification emails sent before 2 April 2019 will reflect the old fees instead of the current fees payable. The applicable fees will be processed accordingly.

Follow the link below for full details:

HSA Website

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