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Working with Other Markets: Pathways, Submissions and Strategies

Posted 03 April 2019 | By Gloria Hall 

Working with Other Markets: Pathways, Submissions and Strategies

Feature articles in March explored working with other markets including global regulatory pathways in China, Japan and New Zealand, the regulation of animal drugs and veterinary medical devices and the complex regulatory pathway for drugs to treat orphan/rare pediatric diseases. Other articles explored risk management and medial device software.
 
Global Regulatory Pathways
 
Senior regulatory consultant, Yingying Liu, discusses Chinese pharmaceutical regulatory issues from two perspectives: the regulatory organizational structure of the responsible government bodies and the regulatory legislative system in “China’s New, Faster Marketing Authorization Approval Program.” Liu reviews changes initiated by the Chinese government aimed at manufacturing and marketing significantly more drugs and encouraging faster delivery of novel drug accessibility to patients in China. Topics include clinical trial review and approval, marketing authorization applications and “special pathways.”
 
“The Chinese Pharmaceutical Market Today” discusses recent pharmaceutical regulatory changes in China aimed at improving the speed of drug innovation, development and clinical trials testing in an effort to get drugs to Chinese patients faster. Regulatory expert Mingping Zhang explores the specific policy changes after the China Food and Drug Administration (CFDA) was renamed the National Medical Products Administration, (NMPA) and subsequently joined the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The author reviews recent regulations aimed at expanding sites for clinical trials, accelerating the clinical trials process and providing better clinical trial data integrity.
 
Regulatory experts Bill Sietsema, Hiroshi Takagi, Tetsuro Seki, Mayumi Miyata, Atsuhiko Kawamoto and Doug Losordo review the latest revision of Japan’s Pharmaceuticals, Medical Devices and other Therapeutic Products (PMD) Act and outline the history and benefits of the SAKIGAKE designation system. In “Japan’s SAKIGAKE Designation System,” the authors share details about the criteria for SAKIGAKE designation and the procedures and timing of SAKIGAKE designation.
 
The current regulatory scheme for medicines in New Zealand (NZ) comprises the 1981 Medicines Act 1981 and the Medicines Regulations 1984. The NZ government intends to replace this out-dated regulatory scheme with a new, “comprehensive regulatory scheme that covers all therapeutic products and is aligned with international regulatory norms.” Renowned professor and program director at the University of South Wales, Orin Chisholm explores New Zealand’s efforts to update its current pharmaceutical regulatory legislation in place since the early 1980s. “New Zealand’s New Regulatory Regime for Therapeutic Products” outlines many of the outdated provisions in the 1981 Medicines Act and the 1984 Medicines Regulation, provides a look at key changes built into the draft of the Therapeutics Products Bill (now open for comment until 18 April 2019) and presents a comprehensive table comparing the 1980s legislation and regulations to provisions in the draft of the new Bill.
 
Animal Drugs
 
Animal drugs and human drugs are regulated similarly in many aspects. However, there are significant differences between them requiring specialized training and experience for planning and submitting animal drug applications to regulatory bodies. In addition, while many countries have similar regulations governing human and animal drugs, the regulatory authority for animal drugs may be under the health authority, including FDA, EMA, Health Canada, South African Health Product Regulatory Authority or Ministry of Agriculture (e.g., Brazil, China, Japan). Biomedical regulatory expert Grace Gowda shares her knowledge in “Planning and Submission Considerations for Animal Drugs,” and discusses the comprehensive planning and streamlining submission considerations by animal health companies to decrease development cost and registration time for animal drugs. The planning and submission considerations are not limited to one country or region but are for worldwide registration of the animal drug. The author covers regulatory pathway considerations, technical requirements and quality, safety and efficacy. The article does not cover vaccines or pesticides.
 
Global regulatory experts Fabrizio Bertani, Melinda Mayfield, Viviana Mascilongo and Sharnée Nichols provide their perspective on the changing regulatory framework for veterinary medical devices .In “Veterinary Borderline Products, Veterinary Medical Devices and In Vitro Diagnostics: Global Regulatory Overview,” the authors site specific examples and related guidelines for manufacturers and distributors within Europe and territories in Switzerland and the UK.
 
Orphan/Rare Diseases
 
Because pediatric medicines and treatments for orphan/rare diseases are considered for unmet medical needs, there has been little development in this area. This was due in part because of the difficulty in conducting clinical trials for rare diseases and concerns associated with a possible smaller return on investment following launch as compared to medicines licensed for common diseases. Parexel experts Bridget Heelan, Victor (Long) Cheng , Nobuyuki Yamagata share their experiences in the complex design of regulatory pathways for orphan/rare pediatric diseases in China, Europe and Japan. While these regions do not have specific regulatory pathways for rare paediatric diseases as separate entities, the relevant paediatric regulations and pathways for approval are explored. “Regulatory Pathways for Orphan/Rare Pediatric Diseases: Global Overview” touches on legislation, criteria for orphan drug designation and regulation, reviews and expedited pathways, incentives and advantages for applicants, such as exclusivity and protection, and gaining marketing approval.
 
Risk Management
 
Over the last 10 to 15 years, with the publication of ICH Q9, risk assessment became a regulatory requirement in the pharmaceutical industry, as well as all areas of medical product development. The concept is expanding over the whole of the life science industry and even the ubiquitous ISO 9001-2015 quality standard is leading practically all businesses to implement risk assessment as a part of their quality system. It is an area always under development and there is a need for continued discussion and exchange of experiences. To address the issue, risk expert Milena Samban explores the need for risk management in the healthcare industry from a personal viewpoint in the article “Risk Management: A Difficult to Implement Regulatory Requirement.”
 
Medical Device Software
 
Three global regulatory experts, Melissa Walker, Sara Jafari and Bakul Patel share their insights into what software can be considered a medical device at the 2018 RAPS Regulatory Convergence. Computer software used in healthcare device applications developed for demographic data gathering, physical examinations or therapies are increasingly part of the regulatory landscape. In their article, “Is Your Software a Medical Device?” the experts explore whether and when computer software, used in a variety of ways in healthcare is, in itself, a medical device. The authors report on recent software and application regulations in both the European Union where medical device regulations were recently revised and the US, where the US Food and Drug Administration (FDA) is responsible for determining how and when software may or may not be considered a “medical device.”
 
What’s Coming in April
 
April’s theme is a global look at biosimilars, and we’ve lined up some of the top regulatory experts to share their insights on similarity approach for complex drugs: biologics and Non-Biological Complex Drugs (NBCDs), comparing data requirements for the approval of biosimilars versus reference medicines and optimizing clinical trials to support the marketing approval of biosimilars. Other articles will explore manufacturing controls at commercial scale—a major hurdle for the cell and gene therapy industry, Chinese health policy and regulatory authority overview, the importance of risk management for over-the-counter drugs and
MRD as a surrogate endpoint for product development in Multiple Myeloma: FDA vs EMA guidance. Look for these and other topics throughout April.
 
Contribute to Regulatory Focus
 
The Editorial Advisory Committee is looking for articles for monthly themes and quarterly topics. If you are interested in contributing, contact ghall@raps.org.

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