FDA Unveils Regulatory Science Progress Report

The report, covering the years 2015 and 2016, points to significant progress in the US Food and Drug Administration (FDA) in refining non-clinical and clinical tools to better evaluate medical products, advancing manufacturing and quality, and Improvement of the internal computer tools to support the applications of regulation of scientific examination.

In the clinic

As for non-clinical predictors, the report indicates that FDA researchers have developed a variety of software tools that are now compatible with the non-clinical evaluation of medical products.

"These tools include sophisticated models to predict the carcinogenic effects of some of the ingredients of drugs based on their structural attributes, mathematical representations of the human body (IT ghosts) that can be used to predict the effects of medical devices, such as Radiation exposure, and mechanically-informed pharmacokinetic models to help predict drug exposure in populations where it is difficult to obtain clinical data, "according to the report.

The FDA has also developed in vitro methods and tools to better understand the properties of drugs and biologicals, including vaccines and new tools to support the assessment and development of medical imaging technologies.

Genetic approaches and transplantation have also been used to create animal models that aim to predict the human response more deeply to medical products, and new physical methods and procedures have been developed to support generic bioequivalence assessment of generic drugs.

Clinical evaluation

To better support clinical evaluation of medical products, the FDA engages in the development and evaluation of biomarkers to better predict long-term treatment outcomes or to affect certain patients more likely to be successful treatments.

For example, the FDA notes that its statisticians helped design antibiotic trials that could assess factors related to the development of resistant microorganisms.

In addition, the agency has formed new biomarkers to guide treatment decisions and predict the progression of the disease.

"A long-term research effort to improve cardiovascular risk prediction contributed to the recommendation of the International Conference on Harmonization that the cost-intensive and resource-intensive QT study (required to assess the majority of candidates To drugs) could be replaced by an electrocardiogram - measures based on early-stage clinical studies, "the report said.

He also referred to the FDA's efforts regarding the use of real-world evidence, staff members have expressed concerns in the past.

Through initiatives such as the patient-centered drug development initiative, the Advisory Committee on Patient Commitment to Healthcare Products and the Patient Preferential Initiative, the FDA also incorporates patient views into the Development and evaluation of medical products.

Manufacturing and Quality

The FDA's medical product centers also address scientific issues related to new critical technologies for the manufacture of products to improve the reliability of drug delivery, complex product characterization, quality standards, Approval of product quality and understanding of interactions of regulated products with products of biological systems.

"We have developed the in-house laboratory and computing capabilities to study continuous production with an advanced process control system," the report added. "We have worked with the Biomedical Research and Development Authority (BARDA) to take advantage of continuous manufacturing to minimize vulnerability to domestic, biological and radiological chemistry. We have set in motion the creation of a 3-D printing to understand the factors Which contribute to quality and quality, the performance of implantable medical devices, drugs and combined products made with this new technology.

In addition, the FDA has developed automated approaches to predict critical properties of human stem cell preparations, such as their ability to contribute to bone growth.

Illinois

The agency has launched its "JumpStart" service that allows evaluators to organize, manage and verify the quality of clinical data in ap

European Regulatory Roundup: EU Trade Groups Propose

European Regulatory Roundup: EU Trade Groups Propose Criteria for Deciding EMA’s New Home (2 March 2017)

European business groups propose criteria for deciding the new EMA home

European biopharmaceutical groups have jointly defined the criteria for deciding the new home of the European Medicines Agency (EMA). The three trade groups have detailed their desire that the selection process takes into account six key criteria in a letter to a senior European health official.

The criteria proposed by the European Federation of Pharmaceutical Industries and Associations (EFPIA), EuropaBio and Medicines for Europe aim to minimize the risk of disruption when EMA moved to its present headquarters in London, UK, to join Brexit. EFPIA and its co-signatories are publicly out of the discussions about the country that could host EMA post-Brexit, but according to their criteria they describe the type of place they want to win.

Three of the criteria relate to local regulatory capacity. EMA, with the support of the Medicines and Health Products Regulatory Agency (MHRA), business groups want to ensure that the national regulatory agency of the new host country can strengthen their participation in EU activities. This change should not detract from non-EMA workforce, business groups argue, and as such, the local government must be prepared to increase spending.

The three remaining criteria relate to the more general characteristics of the proposed sites. Commercial groups want the Commission to choose a location with easy access to the airport, communicated with the rest of the EU, adequate local hotel capacity and enough space for EMA meetings and events. Finally, the authors of the letter to the Commission to minimize disruption of personal EMA taking into account the availability of international schools, access to labor markets and social security.

The EFPIA criteria echo the cases submitted by some candidates to host the EMA to date. Denmark, the Netherlands and other countries have talked about their regulatory and scientific capacity and the viability of their cities for people traveling to London. If the EMA fails to convince the vast majority of its staff to move to London with him, the regulator could have trouble providing normal services to its small size. Business groups want to avoid that scenario.

As such, while the letter out of the debate on the city that will host the EMA criteria favor the countries of Western Europe that have the necessary regulatory capacity and facilitate resettlement.

The organizations argued their views in a letter to Xavier Prats Monné, Director General of Health and Food Safety Directorate-General. The responsibility to choose a new site for the responsibility of EMA Monne and the rest of the commission. Officials have yet to come up with a timetable to make the decision, but many people affected by resettlement want clarity this year.

Letter

EMA sharing guidelines on the risks to human health of veterinary medicinal products in groundwater

EMA has issued a directive on the toxicological risk that veterinary medicinal products in groundwater pose to human health. The text proposes a methodology to assess whether the concentration of drug in groundwater poses a risk to the health of humans who drink the contaminated liquid.

Today, regulators consider concentrations above 0.1 mg / l as unacceptable. At lower concentrations, no risk is expected and no regulatory action is required as such. However, EMA now consider whether this is the right approach.

The cut-off point of 0.1 g / l is obtained from the limit of detection of the analytical methods at the moment. The development of more sensitive tests can detect small amounts of contaminants has made possible a new approach. Because some drugs may affect concentrations below 0.1 mg / l, EMA believes that using these new, more sensitive tests is useful in making more informed judgments about the risks of groundwater contamination.

The EMA provides the industry uses two formulas that take into account the acceptable daily intake of an active ingredient, the daily consumption of drinking water, the expected concentration in the groundwater and other variables to determine if the risk to human health is acceptable . If the expected concentration in surface waters exceeds