Resources and Training for Regulatory Professionals
By Sofia Campos Silva, MSc, PharmD -
Published 27 July 2017
This article discusses the knowledge path for regulatory professionals from a career's early stages through specialization. It recommends a variety of ways to keep current on evolving regulatory issues, including on-the-job training, self-education via the Internet, attending conferences, networking, and membership in professional organizations.
Categories: Features, Business and Leadership, Career Development, Regulatory intelligence
Pharmaceutical Cleaning Processes
By John Godshalk, MSE, MBA -
Published 26 July 2017
This article presents a lighthearted look at pharmaceutical industry cleaning processes, cleaning validation and cleaning verification.
Categories: Features, FDA, WHO, Drugs
Tags: Cleaning, Washing, Rinsing, Cleaning Validation
Ten Secrets to Regulatory Success
By Jody J. Savage, MS, MBA -
Published 20 July 2017
This article highlights "10 secrets to success" for regulatory professionals that may not be taught in formal regulatory affairs training programs, but practices the author learned "on the job." It includes suggestions for developing regulatory submissions and the importance of good writing, doing your "homework" and systematizing work procedures.
Categories: Features, Career Development, Communication
Careers in Regulatory Advertising and Promotion
By Dana Huettenmoser, PharmD -
Published 19 July 2017
This article provides an overview of Regulatory Advertising and Promotion (RAP) as a career in the pharmaceutical industry and discusses topics such as potential avenues for starting a career in RAP, qualities required to be successful, and some general career advice, including information on post-PharmD RAP fellowships and the benefits to be gained from serving them.
Categories: Features, Advertising and Promotion, Career Development
Regulatory Career Progression
By Kamila Kawiak, Kavita Patel -
Published 17 July 2017
This article discusses pathways for a career as a regulatory professional and possible career progression from junior to senior to managerial level. It summarizes the skills required for each level and what it takes to move up the corporate ladder. It also provides the responsibilities expected of a regulatory professional in a senior management position.
Categories: Features, Business and Leadership, Career Development, Career Search
Tags: Career Development, Regulatory Profession
FDA Inspections and Outcomes for Oral Solid Dosage (OSD) Manufacturing Facilities
By Sharry Arora -
Published 14 July 2017
The article discusses various types of current Good Manufacturing Practice (CGMP) inspections conducted by the US Food and Drug Administration (FDA) at oral solid dosage forms manufacturing facilities. It also elaborates on types of inspections, approaches to investigations, limitations of these inspections and major inspection outcomes in the event of deficiencies, including 483s, Warning Letters and Establishment Investigation Reports (EIRs).
Categories: Features, US, FDA, Compliance, Drugs, Manufacturing
Tags: Oral Solid Dosage, OSD, Inspections
Pediatric Legislation, Quality Certificates, Global Regulatory Oversight, Biosimilars and a Preview of July
By Gloria Hall -
Published 05 July 2017
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.
Categories: Features, Africa, Asia, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, MHLW, TGA, WHO, Biologics and biotechnology, Clinical, Drugs, Medical Devices, Regulatory intelligence, Submission and registration
Tags: Regulatory Focus, Feature Articles
Medicinal Product Registration in Egypt
By Shweta Menon -
Published 26 June 2017
This article provides an overview of Egypt's New Drug Application (NDA) procedure for imported brand pharmaceutical products, including new chemical entities and biologics. It discusses the various Egyptian Drug Authority (EDA) departments and the required procedures for moving products through registration and into the market.
Categories: Features, Biologics and biotechnology, Drugs, Medical Devices, Submission and registration
Tags: EDA, Egyptian Drug Authority
Syphilis: a Mysterious and Serious Ancient Disease
By Max Sherman -
Published 13 June 2017
This article alerts regulatory professionals to the continued presence of what may be a "forgotten" disease–syphilis. Although syphilis is unique and may be considered a "relic" of the past, it does not belong in the dust bin of history. To the contrary, regulatory professionals may wish to know more about its controversial medical history, epidemiology and clinical manifestations as syphilis remains a serious public health threat in many parts of the world. These issues in addition to the possible serious consequences of untreated syphilis provide a clear rationale for developing a vaccine.
Categories: Features, Drugs
Identification of Medicinal Products (IDMP) Standards Part 4: Technical Approaches to IDMP
By Dieter Schlaps -
Published 12 June 2017
This article discusses IT approaches to support a gap analysis and implementation of the upcoming Identification of Medicinal Products (IDMP) standards with regard to generating, collecting and mapping accurate and correct data prior to submission in an effort to prevent delays in a product reaching the market.
Categories: Features, Europe, US, EMA, FDA, ISO, Biologics and biotechnology, Drugs
Tags: Identification of Medicinal Products, IDMP
Global Harmonization Initiatives, FDA's User Fee Programs, Pediatric Legislation, Conditional Approvals, Quality Certificates and a Preview of June
By Gloria Hall -
Published 06 June 2017
The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in June.
Categories: Features, EMA, FDA, Health Canada, ICH, PMDA, Biologics and biotechnology, Drugs, Medical Devices, Submission and registration
Tags: Regulatory Focus, Feature Articles
Regulating Pediatric Studies: An EU and US Perspective
By Jennifer Sanguedolce, Narissa Mulchan -
Published 05 June 2017
This article presents pediatric regulatory activities conducted by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) and highlights global harmonization efforts, collaborative discussions and regulations for pediatric clinical trials.
Categories: Features, Europe, US, EMA, FDA, Biologics and biotechnology, Clinical, Drugs
Quality Certificates for Small Molecule Drug Product Applications for International Regulatory Submissions
By Monika Jain, PhD -
Published 02 June 2017
This article provides a global overview of the general requirements and issues regulatory professionals may encounter while arranging for a variety of certificates for applications for small molecule drug products to be marketed internationally in the EU, US, Canada, Australia and Japan.
Categories: Features, Japan, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, PMDA, TGA, Drugs, Submission and registration
Tags: Quality Certificates, eCTD, GMP
Conditional Approvals for Early Access to New Medications
By Sharry Arora -
Published 31 May 2017
This article provides insight into Conditional Approvals (CAs) and Conditional Marketing Approvals (CMAs) as developed across several jurisdictions to potentially provide earlier access to new medicines. The author explains the specifics regarding regulatory requirements for obtaining CAs in the European Union (EU), Japan and the US.
Categories: Features, Japan, Europe, US, EMA, FDA, ICH, PMDA, Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration
Tags: Conditional approval, Regenerative medicine
Medicine's Unsung Heroes
By Max Sherman -
Published 31 May 2017
This article 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.
Categories: Features, US, Drugs, Research and development
Navigating the Medical Device User Fee Act (MDUFA)
By Denise Gottfried MS, MBA, RAC, Patricia Maguire, PhD, Angeline Chooi, Adam Eldridge, PhD, Jonathan Gottfried, MBA -
Published 25 May 2017
This article examines the benefits for both FDA and the medical device industry derived from "user fees" authorized by the passage of the Medical Device User Fee Act (MDUFA 2002) and its subsequent reauthorizations.
Categories: Features, US, CDRH, Medical Devices, Submission and registration
Tags: MDUFA, Medical Device User Fee Act, 510(k), PMA, User Fees
Challenges Providing Pharmaceutical Products to Syrian Refugees
By Zeina Sahloul -
Published 24 May 2017
This article discusses the difficulties encountered by medical personnel working with refugees in Syria and delivering pharmaceutical products. It describes relevant regulatory policy and guidance for drug procurement and quality.
Categories: Features, Middle East, WHO, Crisis management, Drugs, Submission and registration
Tags: Syrian Refugee Crisis, Prequalification, UNHCR, Essential Medicines, MSF
ICH Q12 Post Approval Change Management Protocol: Advantages for Consumers, Regulators and Industry
By Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Vijayalakshmi Iyer -
Published 16 May 2017
This article discusses the latest draft of ICH Q12 and significance of harmonizing regulatory requirements across regional borders. It emphasizes how Post-Approval Change Management Protocol (PACMP) can be used as a tool to improve strategic change management and ensure supply chain reliability.
Categories: Features, Europe, US, FDA, ICH, Biologics and biotechnology, Drugs, Quality
Tags: ICH Q12, Post Approval Change Management Protocol, Quality by Design, QbD
Generic Drug User Fee Act (GDUFA): Overview and Proposed Changes for 2018
By Karla Mark-Lantz, PhD -
Published 11 May 2017
This article discusses aspects of the Generic Drug User Fee Act enacted by Congress as part of the Food and Drug Administration Safety and Innovation Act (FDASIA), including fees, changes enabling FDA to speed up reviews, GDUFA goals and proposed changes and impacts as the first five–year phase concludes in 2017.
Categories: Features, US, FDA, Generic drugs, Submission and registration
Regulatory Harmonization Initiatives
By Mukesh Kumar, RAC, Eliane Barras, MSc, Lewis Lau, RAC -
Published 09 May 2017
This article provides an overview of global regulatory harmonization initiatives and addresses how various regulatory and other organizations are working toward improving access to medicinal products, such as pharmaceuticals and medical devices, and increasing quality through internationally harmonized inspection standards.
Categories: Features, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, Oceania, US, APEC, GHTF, ICH, IMDRF, ISO, OECD, WHO, Biologics and biotechnology, Compliance, Drugs, Medical Devices
Thailand's Approach to Drug Quality Assurance: Creation of the Green Book
By Thanita Patthamajinda, RPh -
Published 27 April 2017
This article discusses how Thailand's Ministry of Public Health (MOPH), Food and Drug Administration (Thai FDA) and a number of government and independent health agencies regulate drugs, both new and generic, as well as traditional, nonwestern medicines.
Categories: Features, Asia, Drugs, Quality
Tags: Thailand, Green Book, Quality Assurance
Identification of Medicinal Products (IDMP) Standards Part 3: Steps to Prepare for IDMP Implementation
By Dieter Schlaps -
Published 26 April 2017
This article discusses the gap analysis and preliminary activities necessary to prepare a pharmaceutical company for the upcoming IDMP standards; it is the final article in a three part series on the standards and their respective implementation guidelines. The first two articles presented reasons for the new standard, the driving forces behind IDMP, and the concepts behind the standard as well as the current timelines for introducing IDMP in worldwide markets.
Categories: Features, EMA, FDA, ISO, Drugs
Impact of the Revised EU Clinical Trial Regulation
By Siegfried Schmitt, Federico Bonacci, MD, Daniela Lisini, PhD, Dr. Viviana Mascilongo -
Published 24 April 2017
Clinical Trial Regulation EU No 536/2014 will come into effect in 2018. This article reports on aspects of the revised regulation and evaluates its potential impact on clinical trials conducted to assess medicinal products for human use. It discusses changes impacting the critical role of the Ethics Committees in the approval process for clinical trials as well as the planned, centralized data reporting channel, referred to as "the portal." While revisions to the regulation are still underway, readers will benefit from the assessment of its current status and anticipated developments.
Categories: Features, Europe, EC, EMA, Biologics and biotechnology, Clinical, Drugs
Tags: Clinical Trial Regulation, EU No 536/2014
Amendments to the 21st Century Cures Act: Changing the Regulation of Combination Products
By Robert D. Cumming, Nancy W. Mathewson, Esq -
Published 14 April 2017
This article summarizes regulatory changes impacting how premarket applications for combination products will be reviewed by FDA and procedures and reporting requirements for applicants and FDA as required by the 21st Century Cures Act.
Categories: Features, US, FDA, Biologics and biotechnology, Combination products, Drugs, Medical Devices
Tags: 21st Century Cures Act, Combination Products, Primary Mode of Action, PMOA
Strategies Adopted by Innovator Companies in Response to Biosimilars Competition
By Charu Manaktala, MD, MBBS, Raymond A. Huml, MS, DVM, RAC, Nigel Rulewski, MD -
Published 10 April 2017
This article examines key strategies being adopted by the innovator companies and discusses the impact these strategies are likely to have on the future market for biosimilars.
Categories: Features, Europe, US, EMA, FDA, Biologics and biotechnology, Government affairs, Regulatory strategy, Submission and registration
Tags: Biosimilars, Intellectual Property, Litigation, Patent Extension