Pediatric Legislation, Quality Certificates, Global Regulatory Oversight, Biosimilars and a Preview of July

Posted 05 July 2017 By Gloria Hall


The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in July.

By Gloria Hall

Feature articles over the past several weeks have highlighted global pediatric activities, certificates for small molecule drug products, the New Drug Application (NDA) process in Egypt and the global debate over naming biological products and biosimilars. Other articles covered the IT approaches to support the gap analysis and implementation of the Identification of Medicinal Products (IDMP) standards, groundbreaking achievements in antibiotic development and the possibility of developing a vaccine for syphilis.

Global Regulations

Over the past two decades, considerable progress has been made in developing drugs for pediatric populations and clinical trials for testing. In their article, "Regulating Pediatric Studies: An EU and US Perspective," Sanguedolce and Mulchan present pediatric regulatory activities conducted by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) and emphasize global harmonization efforts, collaborative discussions and regulations for pediatric clinical trials.

From clinical trials to marketing authorization, regulatory dossiers for small molecule drug products are incomplete without the presentation of certain regulatory certificates. Jain reviews regulatory certificates for small molecule drug products manufactured in the European Union, US, Canada, Australia and Japan. "Quality Certificates for Small Molecule Drug Product Applications for International Regulatory Submissions" also discusses World Health Organization (WHO) Certification.

Egypt, with more than 92 million inhabitants, is the most highly populated nation in North Africa and the Arab world. As a result of modernization, Egypt is emerging as a highly desirable market for pharmaceutical companies wanting to expand their global presence. Menon provides an overview of Egypt's New Drug Application (NDA) procedure for imported brand pharmaceutical products, including new chemical entities and biologics in the article "Medicinal Product Registration in Egypt" and discusses the various Egyptian Drug Authority (EDA) departments and the required procedures for moving products through registration and into the market.

Policy and Guidance

Conventions and regulations for naming biosimilar products have been widely discussed, especially with regard to ensuring patient safety. Trivedi tackles the continuing debate and contracting views among health authorities in Australia, Canada, Europe, Japan and the US regarding conventions for naming biological products and biosimilars. The article "Biological Products and Biosimilars: Global Naming Debate," presents the World Health Organization's (WHO) proposal for naming and the importance of a clear distinction between biologics to avoid confusion and ensure patient safety.

Schlaps discusses IT approaches to support a gap analysis and implementation of the upcoming Identification of Medicinal Products (IDMP) standards. The article "Identification of Medicinal Products (IDMP) Standards, Part 4: Technical Approaches to IDMP" outlines how to generate, collect and map accurate and correct data prior to submission in an effort to prevent delays in a product reaching the market.

Regulatory Research

Sherman contributed two articles in June. "Medicine's Unsung Heroes" introduces readers to Boyd Woodruff, a legend in the field of microbiology, and discusses his groundbreaking achievements in antibiotic development and Merck's research laboratories. In the article, "Syphilis: a Mysterious and Serious Ancient Disease," Sherman alerts regulatory professionals to the continued presence of syphilis as a serious public health threat in many parts of the world, and its controversial medical history, epidemiology and clinical manifestations.

Feature Articles Coming Throughout July

Feature articles throughout the month of July will present various types of inspections conducted by FDA, risk management challenges in the medical device industry and cleaning validation. Other articles cover regulatory affairs as a profession, including careers in regulatory advertising and promotion, regulatory career progression resources and training for regulatory professionals.

Look for these feature articles throughout July.

If you have a suggestion for a feature article, contact me at

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Categories: Biologics and biotechnology, Drugs, Medical Devices, Clinical, Regulatory intelligence, Submission and registration, Features, US, Canada, Europe, Asia, Africa, Oceania, FDA, EMA, Health Canada, MHLW, TGA, WHO

Tags: Regulatory Focus, Feature Articles

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