Evolving Global Regulatory Landscape, Strategies and Best Practices

Feature ArticlesFeature Articles | 31 October 2019 | Citation

October feature articles reported on a number of timely issues facing regulatory professionals today, including the advantages of using periodic safety update reports, practical solutions to pharmaceutical labeling challenges and best practices and strategies to manage global projects. Experts discussed a process to reform the medicinal products authorization system in China, illustrated the
the need for regulatory requirements for ‘herbasimilars’ and introduced readers to an unknown drug safety advocate.
China Regulations
“Bundling review” is a regulatory procedure specific to China in support of the Chinese government’s goal to reform the medicinal products authorization system. Senior regulatory consultant, Yingying Liu, describes the bundling review process, aimed at simplifying and speeding up the review of new drugs with previously approved active pharmaceutical ingredients, excipients and primary packaging materials. In “Bundling Review for Active Pharmaceutical Ingredients, Excipients and Primary Packaging Materials in China,” Liu translates information contained in several annual regulatory updates to the 2015 guidance, highlighting some of the responsibilities of manufacturers and marketing authorization applicants under the new process.
Regulatory Best Practices and Requirements
Global regulatory projects offer multiple layers of complexity and the differing requirements must be navigated, expert advice provided and volumes of information compiled in carefully planned logistical succession. In “Global Regulatory Projects: Best Practices,” regulatory authority, Mary Nteris, illustrates the complexity of managing global regulatory projects and describes considerations and best practices to successfully implement a global strategy.
Even though more than 80 percent of the world population relies on plant-based medication and there are thousands of known and widely used herbal treatments and expert-accepted botanicals to treat cancer, there are still only two FDA approved botanicals commercialized as drugs in the US today. Authorities, Eran Steinberg and Thomas Colona, discuss the plausibility of defining a “similarity” classification for botanical drugs (the Green Book) akin to the Orange Book for generics and the Purple Book for biosimilars. In “Botanical Drugs Herbal Equivalent: Herbasimilars,” the authors argue that FDA should ease its totality of evidence evaluation in order to satisfy herbal regulatory similarity requirements. Is it time for the Green Book?
Labeling Challenges
A health authority-approved pharmaceutical product label contains key information and data intended to educate healthcare providers and/or patients about how to safely use and prescribe a medication. As a result, the label’s content is highly regulated and closely monitored by health authorities. Regulatory experts, Ankith Devunapalli and Alexa Vasios, discuss aspects of the labeling process important to ensuring product labels are accurate and consistent. In “Practical Solutions to Pharmaceutical Labeling Challenges,” the authors cover important aspects of labeling to keep labels up-to-date, to stay health authority-compliant and remain safe for patients. They review label information for both end-to-end and source-to-product labels as well as identify challenges and offer solutions regarding label version control, label proofing, tracking and inter-departmental communication.
Drug Safety
In the late 1950s and early 1960s, the drug thalidomide sent shock waves worldwide when it was proven that it caused debilitating birth defects. While more than 8000 children were born with deformities, the US escaped practically unscathed due in part to physician Dr. Helen Taussig whose testimony before Congress helped support and augment the decision to deny approval. Regulatory veteran, Max Sherman, reviews the biography of Dr. Helen Brooke Taussig and discusses her successful efforts in the 1960s to prevent thalidomide from being FDA-approved for use in the US in “Helen Brooke Taussig: An Often Overlooked Advocate for Drug Safety.”
Periodic Safety Update Reports (PSURs) are one of the main tools used to monitor the safety of products and facilitate post-authorization communication between Marketing Authorization Holders (MAHs) and regulators. Senior regulatory affairs associate, Mariana Cunha, discusses the importance of PSURs in the EU during a drugs’ lifecycle. “Are the periodic safety update reports a useful pharmacovigilance tool in the EU?” also details the PSUR EU single assessment procedure, providing information on the stipulated timelines, what is published by the European Medicines Agency (EMA) and some aspects to be considered when writing a PSUR. A short reference is also made to the informal work-sharing procedure for follow-up for periodic safety update report single assessments for nationally authorized products (PSUFU), since this may be of interest to the reader as it is closely related with the article’s topic.
What’s coming in November?
November feature article will bring together a variety of key regulatory issues facing decision makers today including building consumer digital health and safety standards, developing digital drug information based on real‑world effectiveness tests, regulatory cybersecurity requirements for medical devices and emerging digital health solutions. Global experts will report on the continued importance of consumer access to Chinese medicine and considerations for using human factors medical device regulatory submissions. Look for these topics and more throughout November.
Q1 2020 Call for Articles
Regulatory Focus is looking for subject matter experts to contribute articles to the Q1 2020 topic “the strategic role of the regulatory professional.” See below the themes and deadlines for January, February, March and the Q1 Series.
January - The Vital Role of Regulatory Within Organizations and Throughout the Product Lifecycle
Regulatory affairs touches all aspects of the product lifecycle, including the development, registration and post-registration phases. The actual activities can be different in each phase, but the responsibility of the regulatory professional encompasses both strategic and tactical deliverables. The articles on this theme address the ever increasing role and importance of the regulatory professional in each of these phases.
Article Deadline: 2 December
February - How to Communicate With Various Stakeholders (CEOs, Legislators, etc.) About why Regulatory is Important
Article Deadline: 6 January
March - Regulatory Ethics and History
Ethics is the assumed hallmark and unequivocal standard behind all elements of regulatory affairs and compliance.  This issue seeks to examine various perspectives on this essential concept.  Desired contributions will explore ethics and compliance with broad applicability to the field.  Articles are sought evaluating:
  • The evolution of regulatory compliance from examples of breaches that shaped current practices.
  • Delineation of the standards to be followed in maintaining a daily pattern of compliance in regulatory activities.
  • What, if any, “special” standards or activities must be followed to ensure ethics in specific elements of product evolution such as clinical studies or advertising/marketing.
  • Current trends in the enforcement of regulatory ethics. 
Article Deadline: 3 February
With the need of regulatory science to keep up the pace with increased innovation and complexity of medical products, the role of the regulatory professional has become ever more strategic. As such, the Q1 2020 Regulatory Focus article series will explore the expanding strategic role of the regulatory professional.
Final Article Deadline: 6 January
Release Date/Email to Members: Monday, 2 March
Ask Me Anything: Wednesday, 8 April
If you are interested in writing on any of the above topics or have a recommendation, email Gloria Hall at ghall@raps.org.


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