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Sep 27, 2017

New USFDA Draft Guidance on submitting REMS in SPL Format
Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling Guidance for Industry

On September 5, 2017 the U.S. Food and Drug Administration (FDA) published a draft guidance on Providing Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies (REMS) Document Using Structured Product Labeling (SPL). SPL is an electronic data standard used for capturing information about drug products and is used by the FDA as a mechanism for efficiently exchanging product and facility information. While SPL is most well known as a means for capturing labeling information, the standard has wide-ranging utility beyond this purpose. The availability of REMS information in SPL format will make REMS information more easily accessible. It will also facilitate integration into health information technology, making it easier for health care providers to comply with REMS, reducing their burden, and enhancing the safe use of drugs with REMS.

This guidance describes the benefits of utilizing SPL to submit REMS documents and explains how to submit REMS in the SPL format. It also begins the process of making the submission of REMS in SPL a requirement. Under the Food and Drug Administration Safety and Innovation Act (FDASIA), the requirement will go into effect 2 years after the draft guidance is made final. FDA encourages interested parties to submit any comments on this draft guidance via the associated docket within 180 days of September 5, 2017.

Final USFDA Guidance on Real World Evidence and Medical Devices
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

Real World Evidence (RWE) can exist across a wide spectrum, ranging from observational studies within an existing dataset to studies that incorporate planned interventions with or without randomization at the point of care. Because of the rapidly advancing methodology for generating and interpreting RWD, this guidance will not elaborate on the methodological approaches that can be used. However, when reviewing the use of RWE to support a regulatory decision, FDA will rely on scientifically robust methods and approaches to determine whether submitted RWE is of sufficient quality to support a particular regulatory decision.

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USFDA is advancing the Goals of the Orphan Drug Act
An Update from the USFDA Commissioner on the achievements to date

Three months ago, the agency committed to fully eliminate a backlog of about 200 orphan drug designation requests that were pending review with FDA, and to implement policies that would require FDA to respond to all new designation requests within 90 days of receiving them. Moreover, the agency pledged to never allow a backlog of these designations to accumulate again. Please read the full blog by Scott Gottlieb, MD, Commissioner USFDA:

Read more online

Patient safety: Commission adopts acts on Good Manufacturing Practices for medicines
Focus on Marketed Products and Investigational Medicinal Products

The European Commission adopted two legal acts aimed at improving patient safety in the EU through good manufacturing practices (GMP) that ensure the highest quality of medicines for human use.

The principles and guidelines for GMP set out in these acts take into account recent updates to the well-established EU rules on the safety of medicines.

Whether a medicinal product is already on the market, or still undergoing a clinical trial, the newly adopted acts aim to ensure the highest level of quality for medicines for the benefit of the patients as well as consistency between the GMP requirements for both types of medicinal products.

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China FDA to issue catalogue of all drugs marketed in China
A Chinese Version of the USFDA’s “Orange Book” will be available soon

The China Food and Drug Administration (CFDA)’s Center for Drug Evaluation (CDE) issued draft rules that will underpin the development of a catalog of all drugs listed on the China market – in other words, a Chinese version of the U.S. FDA’s Orange Book. The CDE is solicited public feedback until September 15, 2017.

New Pharmacovigilance (PV) Inspection Guide by Australian Health Authority
The Therapeutics Goods Administration (TGA) issued a new guidance for medicine sponsors on PV

The Therapeutic Goods Administration (TGA) conducts a range of pharmacovigilance activities to monitor the safety and efficacy of medicines in Australia and, where necessary, take appropriate action.

The pharmacovigilance responsibilities of sponsors of medicines included on the Australian Register of Therapeutic Goods (ARTG) and regulated by the TGA are set out in the Pharmacovigilance responsibilities of medicine sponsors—Australian recommendations and requirements.

The TGA inspects Australian sponsors to assess whether they are meeting their pharmacovigilance responsibilities.

This guidance will help sponsors understand TGA’s pharmacovigilance inspection program (PVIP). It outlines how TGA prepares, conducts, reports and follows up pharmacovigilance inspections and lists the criteria TGA uses when scheduling inspections.

Read the pdf


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