Regulatory Business and Strategy, Medical Device Regulations, Adverse Event Reporting Requirements and a Preview of April

Posted 05 April 2017 By Gloria Hall

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

Feature articles over the past several weeks have highlighted regulatory intelligence tools, the importance of collaboration between commercial and regulatory functions, regulatory activities for establishing a joint venture in Japan and successful strategies for outsourcing. Other articles explored key elements of FDA's latest draft guidance on submitting a new 510(k) for medical device hardware and software design changes, regulations on the use of chemical components in medical devices, serious adverse event reporting requirements in the US, the establishment of a regulatory agency in Pakistan and new guidance in Australia on autologous stem cells and tissue therapies.

Regulatory Business and Strategy

When tasked with something new or different in regulatory, sometimes the hardest challenge is knowing where to find the information. In their article, "2017 Regulatory Intelligence Tools Update: Drugs," Brown-Tuttle and Bowen provide tools, links and places to gain access to data on approvals, summaries of approvals, drug labels, global regulatory agency websites and global clinical trial registries for endpoint evaluation.

Building a strong relationship between a firm's commercial and regulatory functions is an important key to a company's success. Cosenza discusses why regulatory and business functions need to work together in label development, launch, promotion, lifecycle management strategy and regulatory intelligence. "The Relationship Between Regulatory and Commercial Organizations: How to Work With Your Commercial Colleagues," also provides successful partnership examples.

Joint Ventures (JVs) with Japanese pharmaceutical companies can be complicated. Koike's article, "Establishing a Joint Venture Pharmaceutical Manufacturing Entity in Japan," describes key regulatory activities for pharmaceutical manufacturing and sales and describes foundation building, marketing authorization holder responsibilities, new drug applications, clinical trial sponsorship, adverse events reporting and brand name registrations as well as requirements for data archiving and post-marketing regulatory activities.

Outsourcing is a strategy and practice for achieving savings, reducing costs, speed or raising quality. Snyder highlights key learnings, helpful approaches and recommendations on how to successfully outsource operation-based regulatory work in his article, "Strategies and Tactics to Successfully Outsource Regulatory Work." He includes tips on knowing the right work to be outsourced, setting expectations, selecting a supplier, overcoming internal resistance to outsourcing, contracting standards and invoicing.

Medical Device Regulations

Ruston gives his opinion on the recently released EU Medical Device Regulation (MDR) and In Vitro Medical Devices Regulation (IVDR) in his article, "MDR and IVDR: the Potential for a 28-Agency, 22-Language Regulatory Process for Medical Devices in the EU."

The design of a medical device often evolves over time and regulatory professionals must assess the impact of proposed design and labeling changes that have previously received marketing clearance from FDA or a preamendments device subject to 510(k). In his article, "When to Submit a 510(k) (Devices and Software): a Regulatory Perspective," Ryberg explores key elements of FDA's latest draft guidance for deciding when to submit a new 510(k) for medical device hardware and software design changes. He discusses the potential business impact and suggests what companies need to do to align with FDA's current thinking.

Whether bringing a new medical product to market for the first time, re-designing an existing product or refurbishing used equipment for resale, manufacturers must understand how regulations dictate design and production processes.In his article, "EU and US Regulations for Chemical Components in Medical Devices," Stanvick discusses a number of regulations directed at the use of chemical components in medical devices, both in the EU and US, offers compliance advice and warns about the penalties of noncompliance.

Global Issues

Timely reporting of Serious Adverse Events (SAEs) is an important aspect of the clinic development process. It enables all stakeholders to have knowledge of real time events to keep patients safe and informed of risks. Fauvelle discusses reporting requirements in her article, "Fast Facts: Serious Adverse Event Reporting Requirements in the US."

Pakistan is one of several countries coming to grips with modernizing its drug regulatory system to ultimately improve the availability, accessibility and affordability of drugs. Hussain highlights the development of a more effective pharmaceutical regulatory environment through the establishment of a regulatory agency in his article, "Drug Regulatory Authority of Pakistan (DRAP): Organizational Structure, Functions and Future Challenges."

The Therapeutic Goods Administration (TGA), the regulating body in Australia, is preparing regulatory guidance on autologous stem cells and tissue therapies that takes into account scientific and regulatory input from many sources. In his article, "Is the Current Regulation of Autologous Stem Cells Appropriate?" Prosser discusses regulating these cutting edge products and addresses safety and efficacy of cell therapies, which therapies are regulated, what regulators are doing in other countries and "next steps" in cell and tissue regulation.

Feature Articles Coming Throughout April

Feature articles throughout the month of April will present strategies adopted by innovator companies in response to biosimilars competition, issues facing biosimilar intellectual property in the US, the revised Clinical Trial Regulation EU No 536/2014and the role of the Ethics Committees, amendments within the 21st Century Cures Act impacting how combination products are regulated and part three of the IDMP standards series on the global impact of the standards and implementation guidance. Other articles will address key changes to FDA's major user fee programs (PDUFA VI, MDUFA IV and GDUFA II), regulatory harmonization initiatives and quality assurance of generic drugs in Thailand. Look for these feature articles throughout April.

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Categories: Human cell and tissue, Medical Devices, Business Skills, Features, US, Europe, Asia, Oceania, FDA, EC

Tags: Features, Regulatory Focus

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