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Oct 5, 2020

The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls
On 29 September 2020 the FDA announced the availability of the draft guidance for industry. Comments can be submitted until 30 November 2020.

This guidance provides general recommendations regarding the development, evaluation, and use of physiologically based pharmacokinetic (PBPK) analyses for biopharmaceutics applications employed by sponsors of investigational new drug applications, and applicants for new drug applications, or abbreviated new drug applications, and supplements to these applications, for oral drug product development, manufacturing changes, and controls. PBPK analyses use models and simulations that combine physiology, population, and drug substance and product characteristics to mechanistically describe the pharmacokinetic (PK) and/or pharmacodynamic behaviors of a drug product.

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Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe
On 28 September 2020 the FDA announced the availability of the draft guidance for industry.

This guidance is intended to assist applicants of abbreviated new drug applications (ANDAs), which were submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)), in responding to complete response letters (CRLs) from the FDA. As described in regulation, ANDA applicants are required to take action after receiving a CRL. This guidance provides information and recommendations regarding potential courses of action for an ANDA applicant after issuance of a CRL, as well as the actions that the FDA may take if the applicant fails to respond to that CRL.

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ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs
On 28 September 2020 the FDA announced the availability of the final guidance for industry.

This guidance is intended to assist applicants in preparing and submitting amendments to tentatively approved abbreviated new drug applications (ANDAs), including requests for final approval. This guidance provides recommendations on the timing and content of amendments to tentatively approved ANDAs to facilitate submission in a timely fashion to enable final approval on the earliest date on which the ANDA may lawfully be approved based on patent and/or exclusivity protections ("earliest lawful ANDA approval date").

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Updated FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency
On 28 September 2020 the FDA updated the final guidance for industry, investigators, and institutional review boards.

FDA is issuing this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency. The appendix to this guidance further explains those general considerations by providing answers to questions that the Agency has received about conducting clinical trials during the COVID-19 public health emergency.

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The ICH Q3D(R2) Draft Guideline Available Now on the ICH Website
On 25 September 2020 the ICH Q3D(R2) draft guideline on elemental impurities reached step 2 of the ICH process.

The extracts with the amendments to the ICH Q3D(R2) draft Guideline for Elemental Impurities, which show the revisions to Appendix 2 and 3 further to corrections of the Permitted Daily Exposure (PDEs) for Gold, Silver and Nickel as well as a new Appendix 5 on Limits for Elemental Impurities by Cutaneous and Transcutaneous Route, reached Step 2b of the ICH Process in September 2020 and now enters the consultation period.

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Guideline on Registry-based Studies
On 24 September 2020 the EMA issued the draft guideline on registry-based studies.

A registry-based study is an investigation of a research question using the infrastructure of (a) new or (an) existing registry(ies) for patient recruitment and data collection. A registry-based study may be a clinical trial, to which the provisions of Directive 2001/20/EC or of Regulation (EU) No 536/2014 (when it becomes applicable) apply, or a non-interventional study if it fulfills the corresponding requirements specified in Directive 2001/20/EC (see Annex of Questions & Answers document, Version 11.0, May 2013) or Regulation (EU) No 536/2014 1 (1). A registry-based study may apply primary data collection and/or secondary use of data collected in a patient registry for another purpose than the given study (see definitions in Appendix 1). A patient registry is defined in this Guideline as an organized system that collects data and information on a group of people defined by a particular disease or condition, and that serves a pre-determined scientific, clinical and/or public health (policy) purpose. The use of the term ‘patient’ in combination with ‘registry’ the dataset on health information. The terms ‘people’ and ‘patients’ used in this definition and Guideline are synonyms, independently of the health status of the individual.

The objective of this Guideline is to provide recommendations on key methodological aspects that are specific to the use of patient registries by marketing authorization applicants and holders (MAAs/MAHs) planning to conduct studies. To support these recommendations, aspects of patient registries that regulators consider important for their use in registry-based studies are included in the Annex. Relevant legal basis and regulatory requirements that apply to these studies are listed in Chapter 4.

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European Medicines Regulatory Network (EMRN) COVID-19 Business Continuity Plan
On 18 September 2020 the EMA announced the availability of the updated EMRN COVID-19 business continuity plan.

The COVID-19 pandemic has been affecting the whole European Medicines Regulatory Network (EMRN) (regulatory network of National Competent Authorities (NCAs) of the Member States (MSs) of the European Economic Area (EEA), the European Medicines Agency (EMA) and the European Commission (EC)), albeit to a different extent and not necessarily at the same time. Several factors have to be taken into account, such as the resources needed to respond to the pandemic as well as the unavailability of staff due to illness or the need to look after children or sick family members.

The aim of this document is to describe

  • the agreement reached within the EMRN as to the principles for the handling of regulatory procedures in a business continuity context in the frame of the COVID-19 pandemic;
  • how these arrangements are implemented for both centrally (CAPs) and nationally authorized products (NAPs).

The arrangements for CAPs and EMA procedures are provided in Annex 1, for NAPs-human medicines in Annex 2, and for NAPs-veterinary medicines in Annex 3.

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Inclusion/Exclusion Criteria for the “Important Medical Events” List
On 18 September 2020 the EMA published the inclusion/exclusion criteria for the “Important Medical Events” list.

The EudraVigilance Expert Working Group (EV-EWG) has coordinated the development of an Important Medical Event Terms (IME) list. This IME list aims to facilitate the classification of suspected adverse reactions as well as aggregated data analysis and case assessment in the frame of the day-to-day pharmacovigilance activities of stakeholders in the European Union. The IME list is intended for guidance purposes only. Inclusion/exclusion criteria for the “Important Medical Events” (IME) list were developed during review of the current list for maintenance related to MedDRA Version 12.1. They have been updated to the current version of MedDRA.

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Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry
On 15 September 2020 the FDA announced the availability of the draft guidance for industry. Comments may submit by 16 November 2020.

This guidance is intended to assist applicants of human prescription drug and biological products in determining the appropriate placement and content of geriatric information in labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products. , The goal of this guidance is to provide recommendations to help ensure that appropriate information on the use of prescription drugs in geriatric patients is consistently placed in the proper sections and subsections within labeling so that the information is clear and accessible to health care practitioners and includes content that guides the safe and effective use in geriatric patients.

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Eosinophilic Esophagitis: Developing Drugs for Treatment
On 15 September 2020 the FDA announced the availability of the final guidance for industry.

The purpose of this guidance is to assist sponsors in the clinical development of drugs and therapeutic biologics for the treatment of eosinophilic esophagitis (EoE). Specifically, this guidance addresses FDA’s current thinking regarding clinical trials and development programs for EoE drugs, including recommendations for the necessary attributes of patients for enrollment, trial designs, efficacy considerations, safety assessments, and pediatric considerations.

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Authorizations for Non-conforming Medical Devices
On 1 August 2020 the Swissmedic published the information sheet about the authorizations for non-conforming medical devices.

Medical devices that are placed on the market in Switzerland must have undergone a conformity assessment procedure during which the conformity with the essential safety and performance requirements is checked.

According to Art. 9 para. 4 and para. 5, respectively, of the Medical Devices Ordinance (MedDO; SR 812.213), it is permissible in exceptional cases to place a non-conforming medical device on the market and to put it into service.

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Export Certificates and Manufacturing Certificates for Medical Devices
On 30 July 2020 the Swissmedic published the information sheet about issuing export and manufacturing certificates for medical devices.

Based on the Therapeutic Products Act (TPA) and the Medical Devices Ordinance (MedDO), Swissmedic, the Swiss Agency for Therapeutic Products, issues export certificates (Free Sales Certificates, FSC) and manufacturing certificates (attestations) for medical devices exported to third countries. Swissmedic can issue those certificates to companies (natural and legal persons) located in Switzerland, provided they supply the required supporting documentation. Swissmedic does not issue export certificates or manufacturing certificates to companies located outside Switzerland.

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