The revisions to US Food and Drug Administration’s (FDA) regulations, announced Tuesday, are designed to remove unnecessary or outdated biologics requirements and allow industry to employ new manufacturing technology and testing capabilities. Issued directly as a final rule – because FDA says it believes the updates include “only noncontroversial amendments” and FDA anticipates no major objections from industry – the new regulations are part of FDA’s continuing effort to...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Outlines Supply Chain Overhaul Following Vaccine Scandal The China Food and Drug Administration (CFDA) has outlined plans to overhaul regulation of the supply chain in the wake of a vaccine scandal currently engulfing the country. Officials are looking to implement a full vaccine traceability system, strengthen oversight of the cold chain and reform the centralized pr...

The ninth meeting of the management committee of the International Medical Device Regulators Forum (IMDRF) took place in Brasília, Brazil, from 8 to 10 March 2016 and included high-level updates on how the group’s seven current work items are progressing and how device regulations are continuing to converge at the international level. Background Originally launched as the Global Harmonization Task Force (GHTF) in 2012, the IMDRF is composed of regulators from Australia,...

President Barack Obama unveiled his final budget request on Tuesday, and though Republicans have said it’s dead on arrival, the US Food and Drug Administration (FDA) would receive an 8 percent increase in funds to help further address drug compounders, device submissions and supply chain security. New ways to combat high prescription drug prices were also included in the request. The overall request from Obama and FDA includes a net increase of $14.6 million in budget au...

The European Commission is bringing together a working group to develop guidelines by the end of 2016 for assessing the validity and reliability of the data that mobile health (mHealth) applications collect and process in order to make these ubiquitous apps more useful for public health. The working group comes as such lifestyle and well-being mHealth (everything from step trackers to heart rate analyzers to weight-loss helpers) has skyrocketed to more than 100,000 apps...

The US Food and Drug Administration (FDA) is looking to shed more light on cases where two or more medical devices packaged together, in what the agency calls a “convenience kit,” would need to comply with unique device identifier (UDI) labeling requirements. According to the draft guidance, the term convenience kit, which the guidance attempts to adjust, “applies solely to two or more different medical devices packaged together for the convenience of the user where they...

Antimicrobial resistance, ensuring timely access to new drugs, increasing transparency and working to harmonize more regulations worldwide are all included in the European Medicines Agency’s (EMA) strategic plan through 2020. The new plan, unveiled Friday, offers 16 objectives around four themes: Contributing to human health, contributing to animal health and human health in relation to veterinary medicines, optimizing the operation of the network and contributing to th...

Regulatory Focus (RF) Interviews Bird Shi, Regional Regulatory Affairs Director, Abbott Nutrition, Greater China. After a career as a researcher at the Institute of Nutrition and Food Safety, Chinese Centre for Disease Control and Prevention (China CDC), Bird Shi became a regulatory affairs director at one of the world's top 500 enterprises. She has witnessed how the regulatory system of China's food industry has improved since its founding and although regulatory affa...

India’s Ministry of Health and Family Welfare (MOHFW) and the Central Drugs Standard Control Organization (CDSCO) met with medical device association representatives earlier this month to discuss how the country can become a hub for device manufacturing and begin to align with global regulations. According to the minutes of the meeting, most of the discussion centered on increasing device exports and evaluating new guidance for industry. Draft guidance on good manufactu...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Adopts Batch of Documents Aimed at Preventing Medication Errors The European Medicines Agency (EMA) has adopted a handful of guidance documents designed to prevent the occurrence of medication errors. In the documents, EMA outlines the best practices for minimizing risk, how to code and assess errors and specific concerns relating to insulin and other diabetes medicin...

A number of the world’s top scientists, policy experts and bio-ethicists met this week in Washington, DC to discuss the implications of human gene editing, and though the focus of the summit was centered more on ethical considerations than regulations, opinions flew on Wednesday over how some new technologies will likely be regulated. Background As Jennifer Doudna, a molecular and cell biologist at University of California, Berkeley, and a leader in the field notes in a...

As gene therapies begin to get a foothold among other cancer treatments, the US Food and Drug Administration (FDA) is taking a more flexible, data-driven approach for the preclinical testing programs of these biologically complex products, according to a new review from five FDA officials in Cancer Gene Therapy . Although FDA has yet to approve a gene therapy to treat cancer, the authors note that about two-thirds of gene therapy clinical trials are for cancer treatment...