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Dec 16, 2019

Qualification Process for Drug Development Tools
On 12 December 2019 the FDA announced the availability of the draft guidance for industry and FDA staff. Comments may be submitted by 7 February 2020.

Section 3011 of the 21st Century Cures Act (Cures Act) added new section 507, Qualification of Drug Development Tools (DDTs), to the Federal Food, Drug, and Cosmetic Act (FD&C Act). This draft guidance meets the Cures Act’s mandate to issue guidance on this section-507 qualification process and related Prescription Drug User Fee Act (PDUFA) VI commitments; the draft guidance of the same name issued January 7, 2014, is withdrawn. Specifically, once finalized, this guidance will represent the Center for Drug Evaluation and Research’s (CDER’s) and the Center for Biologics Evaluation and Research’s (CBER’s) current thinking on taxonomy for biomarkers and other DDTs, and on implementation of section 507 of the FD&C Act with respect to the processes for requestors interested in qualifying DDTs.

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Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with chapter P.III on pharmacovigilance for the use of medicines by pregnant and breastfeeding women
On 11 December 2019 the EMA updated the guidelines on GVP.

New legislation for pharmacovigilance applies in the EU since July 2012, and to support its implementation, a set of guidelines for the conduct of pharmacovigilance in the EU has been developed which, as they have been adopted, replaced the previous set in Volume 9A of the Rules Governing Medicinal Products in the EU.

This new guidance on GVP is organised into two types of chapters, namely Modules on pharmacovigilance processes and Product- or Population-Specific Considerations.

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How will pharmacovigilance look in 2030?
On 10 December 2019 the EMA published the news about the predictions for the key elements of Pharmacovigilance in 2030.

Smarter collection and reporting of safety reports of suspected adverse reactions, measurement of on-market performance of medicines, and improved engagement between regulators, patients and healthcare professionals will be key elements of pharmacovigilance in 2030. These predictions are made in an from Guido Rasi, EMA's Executive Director, Sabine Straus, the chair of EMA's safety committee (PRAC) and Peter Arlett, the Agency's Head of Pharmacovigilance and Epidemiology, published in Clinical Pharmacology and Therapeutics.

Medicines prevent, diagnose or treat diseases, but they also can have side effects. Therefore, their risks need to be balanced against their benefits and only medicines with a positive benefit-risk balance are authorised for marketing in the EU. The European medicines regulatory network has established a robust system for monitoring and managing the risks of medicines on the market. Coordinated by EMA, this pharmacovigilancesystem is designed to enable patients to benefit from medicines while making them as safe as possible.

Pharmacovigilance systems across the globe are changing significantly due to technology advancements, increasing volumes of data available to regulators and companies, and increasing engagement of patients in healthcare decision making. In this context, the authors anticipate three major trends in the next ten years.

Individual case safety reports (ICSR) will continue to be a key data source for detecting potential new safety issues and can be further improved. By 2030, ICSR reporting will be much smarter. New technologies such as e-Health applications, as well as ongoing collaboration between the industry and regulators to revise the (ICH) guideline E2D on post-approval safety data management provide opportunities to optimise the collection and management of ICSRs.

Pharmacovigilance has made great progress in moving from a reactive activity driven solely by spontaneous reports of suspected adverse reactions to a more proactive monitoring activity based on careful planning before the product is placed on the market. By 2030, for key new medicines this monitoring will encompass both the safety and efficacy of medicines and will facilitate real-time decision-making by regulators to optimise the safe and effective use of medicines.

In 2030, regulators will dedicate significantly more time to engaging with patients and healthcare professionals and thus ensuring that the information provided to them is impactful. Here the authors highlight the electronic product information, which will be updated near real-time to support prescription, dispensing, and use of medicines.

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Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids
On 6 December 2019 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 7 February 2020.

The purpose of this guidance is to assist sponsors in the clinical development of locally applied corticosteroid products (including suppositories or products that require an applicator) for the short-term treatment of symptoms associated with internal or external hemorrhoids. Specifically, this guidance describes FDA’s current thinking regarding the recommended attributes of patients for enrollment, efficacy assessments, and safety assessments.

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Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment
On 4 December 2019 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 2 February 2020.

This draft guidance provides FDA's recommendations for clinical trials intended to establish clinical effectiveness and safety for drugs intended to treat Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS).

This guidance incorporates recommendations the FDA received at a December 2017 advisory committee meeting on trial design features, including enrollment criteria and acceptable effectiveness endpoints for drugs intended to treat IC/BPS.

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Guide on access to unpublished documents
On 9 December 2019 the EMA updated the guide on access to unpublished documents.

This document complements Policy 43: European Medicines Agency policy on access to documents (related to medicinal products for human and veterinary use). Policy 43, which applies in the context of the Agency’s activities in the fields of medicinal products for human and veterinary use, has a two-fold approach. The present guide describes how the Agency deals with all written requests, especially requests made electronically, for access to any document originated, received or held by the Agency (i.e. reactive disclosure). The second one concerns proactive disclosure of EMA documents, either through the Agency’s website or other sources of publication.

This guide, developed by the ATD team within the Documents and Publication (DAP) Service, should be read in conjunction with the information already provided by the Agency on the dedicated webpage on Access to Documents.

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China tightens drug administration as law takes effect
China's revised drug administration law, adopted by the top legislature in August, went into effect on Dec 1, as part of the country's efforts to strengthen supervision to ensure drug safety.

Aimed at addressing prominent problems of the pharmaceutical industry, such as counterfeit and substandard drugs and high drug prices, the revised law stipulates the strictest standards and toughest measures in supervision over the whole process of the industry chain, including the research and development, manufacturing, sales, use and management of drugs.

The revised law introduces a "full traceability" mechanism and a drug recall system. It also covers online drug sales, a new area in need of better supervision.

The revision also increases both the lower and upper limits of the penalties in the law. For instance, those who produce counterfeit drugs will be fined 15 to 30 times their earnings, as opposed to two to five times before the revision.

Several occasions are stipulated in the law where heavier punishment is applicable, including producing and selling counterfeit or substandard drugs for children and pregnant women.

The drug administration law was first promulgated in 1984. The revision in August is the first overhaul since a 2001 revision.

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European Medicines Agency’s Privacy Statement concerning requests for information or access to documents
On 26 November 2019 the EMA published its privacy statement explaining requests for information or access to documents

This Privacy Statement explains how the European Medicines Agency (hereinafter “EMA” or “Agency”) collects and uses your personal data for the purpose of handling your request submitted on the AskEMA online form, namely:

  • Requests for access to documents: when handling formal requests for access to EMA documents;
  • Request for information: when handling a request for information from EMA.

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ICH Q12 and Annexes reach Step 4 of the ICH Process
The ICH Q12 and its Annexes reached Step 4 of the ICH Process at the ICH meeting in Singapore on 21 November 2019.

The ICH Q12 Guideline on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management is intended to complement the existing ICH Q8 to Q11 Guidelines and provides a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. The adoption of this new ICH Guideline will promote innovation and continual improvement in the biopharmaceutical sector, and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain adjustments. It will allow regulators (assessors and inspectors) to better understand the firms’ Pharmaceutical Quality Systems (PQSs) for management of post-approval CMC changes.

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