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Feb 18, 2020

 
European Medicines Agency’s privacy statement for public and targeted consultation
On 14 February 2020 the EMA published its privacy statement for public and targeted consultation.

The European Medicines Agency (hereinafter ‘EMA’ or ‘Agency’) is committed to respecting the right to data protection of the public. The Agency collects and uses personal data in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data (hereinafter ‘Regulation’).

This privacy statement explains how the Agency collects and uses personal data for purposes related to public and targeted consultations in accordance with the Agency’s data-protection obligations under the Regulation. The launching and management of public consultations by the Agency involves the collection and processing of the personal data of stakeholders, interested parties and individuals who submit their contributions to these consultations. If you fall into one of these categories, it is important that you read and retain this statement, together with any other privacy statements EMA may provide on specific occasions when it is collecting or using personal data about you, so that you are aware of how and why EMA is using such data, and what your rights are under the Regulation.

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Products Management Services (PMS) -Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
On 11 February 2020 the EMA announced the availability of the guideline of implementation of the ISO IDMP standards.

The ISO IDMP standards specify the use of standardised definitions for the identification and description of medicinal products for human use. The purpose of these standards is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner, by providing a common product ’language’ for stakeholders to use in their interactions.

The use of ISO IDMP standards is required in accordance with Articles 25 and 26 of Commission Implementing Regulation (EU) No 520/2012. These provisions mandate Member States, marketing authorisation holders and the EMA to use ISO IDMP standards for the exchange and communication of information on medicinal products.

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Substances, Products, Organisations, Referentials (SPOR)
On 11 February 2020 the EMA announced the availability of the SPOR Application Programming Interface (API) version 2 specification.

The purpose of this document is to present the description of the intended SPOR API version 2.0, which is based on the international FHIR standard (Fast Healthcare Interoperability Resources), http://hl7.org/fhir

The specifications for the SPOR API are a first step towards implementing the system supporting the API.

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ICH M9 guideline on biopharmaceutics classification system-based biowaivers
On 11 February 2020 the EMA announced that ICH M9 reached step 5 of the ICH process.

This new multidisciplinary guideline is proposed to address biopharmaceutics classification system (BCS)-based biowaivers. BCS-based biowaivers may be applicable to BCS Class I and III drugs, however BCS-based biowaivers for these two classes are not recognized worldwide. This means that pharmaceutical companies have to follow different approaches in the different regions. This guideline will provide recommendations to support the biopharmaceutics classification of medicinal products and will provide recommendations to support the waiver of bioequivalence studies. This will result in the harmonisation of current regional guidelines/guidance and support streamlined global drug development.

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European Medicines Agency privacy statement for the organisation of meetings and events
On 7 February 2020 the EMA published its privacy statement for the organisation of meetings and events.

This privacy statement explains how the Agency collects and uses personal data for purposes related to meetings and events that it organises in accordance with the Agency’s data protection obligations under the Regulation. These meetings and events include:

  • regulatory and scientific meetings including participants representing national competent authorities (i.e. national medicines regulatory authorities for human and veterinary medicines from Member States in the European Union [EU] and European Economic Area [EEA], or NCAs) and experts, as well as representatives of EU institutions and bodies, and international regulators;
  • external stakeholder events including representatives of patients and consumers, healthcare professionals, academia, industry and other stakeholder organisations.

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European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
On 6 February 2020 the EMA updated its pre-authorisation procedural advice for users of the centralised procedure.

This guidance document addresses a number of questions which users of the centralised procedure may have. It provides an overview of the European Medicines Agency’s position on issues, which are typically addressed during the course of pre-submission meetings.

The EMA emphasises the importance of pre-submission meetings between applicants and the EMA/(Co- ) Rapporteur. Pre-submission meetings (which should take place approximately 7 months prior to the anticipated date of submission of the application) are a vital opportunity for applicants to obtain procedural, regulatory and legal advice from the EMA. The product team is available to address any questions MAHs may have regarding their pre-authorisation application.

This guidance information and fruitful pre-submission meetings should enable applicants to submit applications, which are in conformity with the legal and regulatory requirements and which can be validated speedily. Pre-submission meetings will also enable applicants to establish contact with the EMA staff closely involved with the application as it proceeds.

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Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry
On 5 February 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 6 April 2020.

This guidance provides recommendations to applicants seeking licensure under the Public Health Service (PHS) Act of a proposed biosimilar or proposed interchangeable biosimilar for fewer than all of the reference product’s licensed conditions of use. Additionally, this guidance also provides recommendations on the submission of a supplement to a licensed biologics license application (BLA) seeking to add a condition of use that previously has been licensed for the reference product to the labeling of a licensed biosimilar or interchangeable product, including considerations related to the timing of such submissions.

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Quality of medicines questions and answers: Part 1
On 05 February 2020 the EMA updated the questions and answers on matters related to the quality of medicines.

These questions and answers address a number of questions that have been brought to the attention of the Joint Committee for Medicinal Products for Human Use / Committee for Medicinal Products for Veterinary Use Quality Working Party (QWP) by marketing-authorisation holders (MAHs) or European Economic Area (EEA) competent authorities, on matters related to the quality of medicines. They have been developed and are maintained by the QWP.

These questions have been produced to provide clarification or additional information, and should be read in conjunction with the European Pharmacopoeia, quality guidelines and other guidance documents.

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EMA to support development of vaccines and treatments for novel coronavirus disease
On 04 February 2020 the EMA announced to support development of vaccines and treatments for novel coronavirus disease.

To contribute to the global response to the outbreak of the novel coronavirus (2019-nCoV) infections, EMA is taking concrete actions to accelerate the development and availability of medicinal products for the treatment and prevention of the new coronavirus.

The Agency is surveying the landscape for potential antivirals or vaccines to treat or prevent novel coronavirus infections. EMA is also analysing all available information on developers’ drug pipelines.

Developers working on medicinal products or vaccines that could be used for treatment or prevention of novel coronavirus 2019-nCoV infections are encouraged to contact the Agency and discuss their strategy for evidence generation as soon as possible. They can contact EMA by sending an email to 2019-nCoV@ema.europa.eu for initial discussions with EU regulators.

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Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment Guidance for Industry
On 4 February 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 3 April 2020.

The purpose of this draft guidance is to foster greater efficiency in drug development in this rare disease with the goal of enhancing clinical trial data quality and supporting the development of treatments for mucopolysaccharidosis type III. Specifically, the draft guidance provides the Agency's current recommendations regarding eligibility criteria, trial design considerations, and efficacy endpoints for use in clinical development programs of investigational drugs to treat mucopolysaccharidosis type III.

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European Medicines Agency - Privacy statement for Selection and Recruitment
On 03 February 2020 the EMA updated its privacy statement for selection and recruitment.

The European Medicines Agency (EMA or Agency) is committed to respecting the privacy of its candidates for recruitment. Within the framework of the staff selection and recruitment procedures at EMA, all personal data provided by candidates are dealt with in compliance with Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data.

This statement explains how the EMA collects and uses the personal data provided by candidates within the different stages of the staff selection and recruitment procedures.

The Agency processes the personal data contained in this e-recruitment portal, and provided by candidates outside of it, in accordance with Regulation (EU) 2018/1725, for the purpose of selection and recruitment at the European Medicines Agency. The Agency does not make public the names of successful candidates on the reserve lists. For recruitment purposes members from the management team of the Agency have access to data relating to candidates on the reserve lists and to their application form. Anonymised statistical information will be used for human resource planning purposes.

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Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry
On 3 February 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 2 April 2020.

FDA is issuing this guidance to provide manufacturers, packers, distributors, and their representatives (firms) with information to consider when developing FDA-regulated promotional labeling and advertisements (promotional materials) for prescription reference and biosimilar products licensed under the Public Health Service Act (PHS Act). Although the guidance covers promotional issues involving both reference and biosimilar products, some questions and answers are focused on only biosimilar product promotional materials. The guidance does not discuss considerations unique to promotional materials for interchangeable biosimilars.

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