Featured Articles

In-depth examination and analysis of regulatory and related topics, available exclusively to RAPS members.

South Africa Medicines Regulatory System Overview

South Africa’s pharmaceutical regulating body, the Medicines Control Council (MCC), is staffed to review a dossier completely to international standards, and it conducts its own review of the complete dossier, regardless of other major regulatory approvals. In the last decade, limited resources have meant increased review timelines. To ensure a timely and successful application, it is crucial for pharmaceutical companies to facilitate open discussions and exchange information with key MCC regulators, listed herein.

Categories: Drugs, Government affairs, Submission and registration, Features, Africa Tags: South Africa, Medicines Control Council, responsible pharmacist, harmonization initiative, CTD, dossier
Writing Skills for the Regulatory Professional

Later this year, RAPS will publish a new book, Regulatory Writing, co-authored and edited by Mukesh Kumar, PhD. This article is an introductory overview of his upcoming book and demonstrates that strong writing skills are a core competency of regulatory professionals.

Categories: Medical writing, Project management, Features, Communication Tags: writing skills, technical writing, writing training
'Cafeteria-Style' Approach to Training for the Regulatory Technical Writer

A flexible training methodology, referred to as the "cafeteria-style" approach, provides effective, efficient instruction for onboarding regulatory technical writers. This style of training is also useful in providing ongoing professional development for current staff.

Categories: Medical writing, Project management, Features, Communication Tags: regulatory writing, training, regulatory technical writers, training buckets
Writing Regulatory Documents with E-Submissions in Mind

Preparing regulatory documents for electronic submission (known as publishing) can be time consuming and complicated. This article offers some practical tips to help authors prepare regulatory documents in a more efficient manner, which can shorten submission timelines and save resources.

Categories: Medical writing, Project management, Submission and registration, Features Tags: electronic submissions, cross-referencing, hyperlinks, eCTD, templates, style guides, leaf titles
Types of In Vitro Diagnostics: Clearing Up the Confusion

In vitro diagnostics: It is easy to get lost in a seemingly foreign language of acronyms for IVDs—ASRs, RUOs, LDTs and more. Can a company explain the differences between ASRs and LDTs—not to mention RUOs, IUOs, “home brew” tests and companion IVD diagnostics? An overview of the various types of IVDs.

Categories: In vitro diagnostics, Features, US, FDA Tags: FDA, in vitro medical devices, IVDs, FDA guidance, GPRs, CLIA
Integrated Summaries of Effectiveness and Safety: Writing in the Context of the CTD

Two common approaches to writing Integrated Summaries of Effectiveness and Safety (ISE and ISS, respectively) and the Summaries of Clinical Efficacy and Safety are discussed, with the focus based on medical writers’ experience with document preparation for a US NDA or BLA. However, given that the Common Technical Document (CTD) format is accepted in the US, the EU and Japan, the same strategies also can be applied to those regions.

Categories: Biologics and biotechnology, Drugs, Medical writing, Submission and registration, Features, US, FDA Tags:
China FDA 'Flying Inspections' for Drugs: How They Work

The China Food and Drug Administration conducts special drug manufacturing inspections without advanced notice. These so-called “flying inspections” are in addition to regular GMP inspections. The article provides a summation of the key elements of CFDA’s proposed flying drug regulation, including its objective, scope, inspectors’ responsibilities and process.

Categories: Active pharmaceutical ingredients, Drugs, Compliance, Manufacturing, Features, China, CFDA, APIs Tags:
Fruit Flies––Powerful Foot Soldiers in Genetic Research

Fruit flies have revolutionized biological science since their research use began in earnest in the early 20th century. Some recent studies using fruit flies may have an impact on treatments for alcoholism, drug abuse, neurological and behavioral diseases, sleep, tumors and diabetes.

Categories: Drugs, Preclinical, Research and development, Features Tags: Fruit flies, Drosophila, research, genetics, history
Northern Africa: Regulatory Submission Considerations for the Region

Northern Africa is an emerging region presenting unique regulatory submission considerations.  Although sponsors usually seek to re-use key portions of a submission dossier to apply for approval in multiple Northern African countries, each national regulatory authority maintains specific regulations and procedures.

Categories: Drugs, Distribution, Regulatory strategy, Submission and registration, Features, Africa, FDA, EMA, WHO Tags: Africa, Northern Africa, regulatory submissions, Western Sahara, Mauritania, Morocco, Algeria, Tunisia, Libya, Egypt, Sudan
Canada and the Orphan Drug Framework--Where Are We Now?

Canada is in the final stages of developing an orphan drug policy for drugs affecting populations of 5 in 10,000 people. Bill C-17 has passed the legislature and is awaiting final approval. The new policy will then be open for comment. Fee mitigation, accelerated review and HTA collaboration are incentives but marketing exclusivity is not, although discussions on that topic are taking place. The final hurdle is provincial and private payment plans.

Categories: Prescription drugs, Orphan products, Government affairs, Reimbursement, Features, Canada, FDA, EMA, Health Canada Tags: orphan drugs, Bill C-17, Vanessa's law, payment plans
Applying Ethics to Conflicting Healthcare Philosophies: The Ebola Example and the RAPS Ethics Code

How regulatory professionals can apply the RAPS Code of Ethics to current and future endemic disease outbreaks characterized by a rapidly developing healthcare situation and quickly evolving knowledge base regarding prevention, treatment and potential cures.

Categories: Drugs, Ethics, Features, Africa Tags: Ebola, emerging diseases, treatments, prevention, potential cures
US Orphan Drug Exclusivity Criteria Clarified in Depomed Court Decision

Key points and observations about a recent federal court decision on orphan drug exclusivity as outlined in the case of Depomed v. US. The central issue concerned what conditions a drug must satisfy to qualify for marketing exclusivity.

Categories: Generic drugs, Orphan products, Features, US Tags: Depomed v US, orphan drugs, Neurontin, Gralise, post-herpetic neuralgia, exclusivity, clinical superiority
The Southeast Asian Regulatory Environment for Pharmaceuticals (Part 1)

A two-part series on the Southeast Asian regulatory environment for pharmaceuticals describes the regulatory landscape in each of the 10 Association of Southeast Asian Nations (ASEAN) countries and attempts to capture some of the key elements that companies should consider when planning to enter ASEAN markets. Part 1 presents information on the larger markets of Singapore, Malaysia, Thailand, the Philippines and Indonesia. Part 2 will discuss Brunei, Vietnam, Laos, Myanmar (Burma) and Cambodia.

Categories: Drugs, Distribution, Submission and registration, Features, Asean Tags: ASEAN, pharmaceuticals, Asian markets, regulatory review, Singapore, Malaysia, Thailand, Philippines, Indonesia, harmonization
RCOREs: African Regional Centres of Regulatory Excellence

African Regulatory Centres of Excellence (RCOREs) were mandated by the African Medicines Regulatory Harmonization (AMRH) initiative. There are currently 10 RCOREs throughout Africa. Their goal is to strengthen regulatory capacity development by providing academic and technical training in regulatory science.

Categories: Government affairs, Features, Africa Tags: Africa, AMRH, RCOREs, regional centres of excellence, regulatory training
US UDI/GUDID Submission Deadlines: What Medical Device Manufacturers Need to Know

The US FDA Unique Device Identification final rule dictates when submissions must be made to the GUDID database. There are four methods to submit the device record. What are the key considerations for future GUDID submissions and how may device manufacturers keep their options in mind?

Categories: Medical Devices, Compliance, Features, US, FDA Tags: US, FDA, UDI, GUDID, medical devices, regulations, Global Unique Device Identification Database
Tumor Paint—A Novel Approach to Enhance Surgical Resection

An experimental imaging agent dubbed "tumor paint" could help surgeons resect tumors with the least amount of damage to surrounding healthy tissues. The tumor paint is being studied in gliomas, among the deadliest forms of cancer.

Categories: In vitro diagnostics, Research and development, Features, FDA Tags:
Asia Regulatory Roundup: Status Quo for Indian Trials; TGA Inspections Lag (11 November 2014)

Welcome to our Asia Regulatory Roundup, a new feature exclusively for RAPS members. Each week our roundup will provide you with the latest, most important regulatory news affecting Asia and the companies operating therein. This week's top news includes Australia's struggle to inspect foreign and domestic drug manufacturing facilities and India's about-face on a reported clinical trials proposal.

Categories: Regulatory intelligence, News, China, India, Oceania, CFDA, CDSCO, TGA Tags: Asia Regulatory Roundup, Regulatory Roundup
European Regulatory Roundup: EMA, FDA Clash Over Ebola Approaches (6 November 2014)

Welcome to our European Regulatory Roundup, a new feature exclusively for RAPS members. This week's edition covers the EMA's approach to regulating experimental Ebola treatments, EMA's new draft guideline on influenza vaccine development, new efforts to harmonize HTA approaches, and more.

Categories: Regulatory intelligence, News, EMA, MHRA, NICE Tags: European Regulatory Roundup, Regulatory Roundup, EU Regulatory Roundup
21 CFR Part 11: The Ins and Outs of One of FDA's Most Difficult Rules

1992 was a different time, when the Internet was still in its infancy and email as a corporate tool was only just beginning to take hold. In the life science industry, there were dreams—then unrealized—of a completely electronic and totally paperless office. And at the US Food and Drug Administration (FDA), regulators were only just beginning to realize the potential effects digital data management systems could have on product development.

Categories: Clinical, Regulatory intelligence, Features, US, FDA Tags: 21 CFR Part 11, 21 CFR 11, Electronic Data, Electronic Recordkeeping, Electronic Records
Asia Regulatory Roundup: China's Biosimilar Guidelines Revealed (4 November 2014)

Welcome to our Asia Regulatory Roundup, a new feature exclusively for RAPS members. Each week our roundup will provide you with the latest, most important regulatory news affecting Asia and the companies operating therein. This week's edition features news on China's new biosimilar guidelines, clinical trial updates in India, China's crackdown on marketers of fraudulent pharmaceuticals, and India's peculiar finding about fake drugs.

Categories: Regulatory intelligence, News, China, India, Oceania Tags: Asia Regulatory Roundup, Regulatory Roundup
Central Africa: Defining a Regulatory Strategy for the Region

  Central Africa presents a number of regulatory challenges to drug manufacturers, beginning with the complexity of dealing with the network of many local and international organizations that provide a framework for drug regulation. This article examines harmonization policies, defining a regulatory submissions strategy and determinants of regulatory success in Central Africa and provides a contact list for the 12 countries that make up the region.  

Categories: Drugs, Regulatory strategy, Submission and registration, Features, Africa, FDA, ICH, WHO Tags:
European Regulatory Roundup: Confusion Remains Over EU Device Oversight (30 October 2014)

Welcome to our European Regulatory Roundup, a new feature exclusively for RAPS members. Each week our roundup will provide you with the latest, most important regulatory news affecting the EU and the companies operating therein. This week's edition features information on an important medical device question in the EU, EMA's efforts to spur development of Ebola treatments, and a new and important change in the regulation of biosimilars.

Categories: Regulatory intelligence, News, Europe, EMA, EC Tags: EU Regulatory Roundup, Regulatory Roundup, European Regulatory Roundup
Asia Regulatory Roundup: India to Accredit Trials in 2015; Singapore Considers Regulatory Overhaul (28 October 2014)

Welcome to our Asia Regulatory Roundup, a new feature exclusively for RAPS members. Each week our roundup will provide you with the latest, most important regulatory news affecting Asia and the companies operating therein. This edition's top stories include India's efforts to accredit more clinical trials, Singapore's attempt to simplify the regulation of pharmaceuticals, and Australia and India's drives toward regulatory efficiency.

Categories: Regulatory intelligence, India, Oceania Tags: Asia Regulatory Roundup, Regulatory Roundup
Two Extraordinary Medical Writers: Lewis Thomas and Sherwin Nuland

Good medical or scientific writing is an integral requirement for regulatory and clinical research professionals. The author presents thoughts on the works of two great practitioners of the craft: Lewis Thomas and Sherwin Nuland.

Categories: Medical writing, Features, Communication Tags: medical writing
China's Regulatory Procedure and Inspection System

Current information on the China Food and Drug Administration regulatory authorities and its inspection systems, including the role of Provincial and City FDAs.

Categories: Active pharmaceutical ingredients, Prescription drugs, Features, China, CFDA, APIs Tags: CFDA, regulatory authorities, Provincial FDA, City FDA, inspection processes
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