News related to Regenerative Medicine, Tissue Engineering, Medical devices, Pharmaceutical industry with focus on achievements and the legal, ethical, and regulatory aspects of the field

Draft Guidance Documents on GLP for public comments

The Organisation for Economic Co-operation and Development (OECD) published draft GLP document on the management, characterisation and use of tested items. The document is designed to provide guidance on: the transportation, identity, receipt, handling, storage, archiving and disposal of all test items used on GLP studies. Test items include agrochemicals, industrial chemicals, pharmaceuticals and biological agents (vaccine, antibody, enzyme, etc.). The scope of the guidance also covers formulated test items and medical devices.

Deadline for comments – 22 June 2017

GCP Renovation – Modernization of ICH E8 and Subsequent Renovation of ICH E6

“ICH is inviting public review and comment on a reflection paper on Good Clinical Practice (GCP) “Renovation”, which contains the ICH proposal for further modernization of the ICH Guidelines related to clinical trial design, planning, management, and conduct. The scope of the proposed renovation includes the current E8 General Considerations for Clinical Trials and further revision to the E6 Guideline for Good Clinical Practice, which is already undergoing modernization with the recent production of ICH E6(R2).”

For detailed information please see the Reflection paper on GCP Renovation

All comments should be submitted before the closing date for public comment, which is March 11, 2017.


FDA’s Draft Guidances for the calendar year 2017

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has published a Guidance Agenda with planned new and revised Draft Guidances for the calendar year 2017.

Changes are expected within documents of several categories: Advertising, Biopharmaceutics, Biosimilarity, Clinical/Antimicrobial, Clinical/Medical, Clinical Pharmacology, Clinical/Statistical, Drug Safety, Electronic Submissions, Generics, Labeling, Pharmaceutical Quality/CMC, Pharmaceutical Quality/Manufacturing Standards (CGMP), Pharmacology/Toxicology, Procedural, User Fees


Agreement between the EEA Heads of Medicines Agencies and the Pharmaceutical Inspection Co-operation Scheme

The Heads of Medicines Agencies of the European Economic Area (EEA HMA) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) signed a Letter of Agreement. The objective of the agreement is the exchange of information after audits among authorities and joint training for GxP inspectors. The agreement came into force August 2016.

Novelty of the medical device Regulation proposal concerning Responsible Person

According to Article 13 of the draft medical device Regulation entitled “Person responsible for regulatory compliance” as lastly amended by the European Parliament, “manufacturers must have available within their organization at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices”. Hence, the main change in medical device Regulation proposal is the requirement that a qualified person of manufacturer’s organization or authorized representative should be responsible for regulatory compliance.

Interestingly, professional experience can replace an academic qualification. In contrast to the requirements for the qualified person for medicinal products, the responsible person for medical devices can rely on either a diploma or a professional experience. Moreover, this amendment of the  European Parliament enables that the role and responsibilities may be shared between several persons responsible for example for one of these tasks: regulatory, production or quality assurance compliance.

More on the topic you can read here and here

ATMP related targeted stakeholder consultation

Several weeks ago, the summary of the responses to the consultation on the development of Guidelines for Good Manufacturing Practice for Advanced Therapy Medicinal Products was announced. It has been developed on the basis of the comments received during the consultation as well as input from consultation with the European Medicines Agency and competent authorities in the Member States. The Commission services developed draft Guidelines on Good Manufacturing Practice (“GMP”) specific to ATMPs.
You can read more at European Commission website.

Stem cells from bone marrow delay diabetes type I progression

In diabetes type I, there is a progressive decline of insulin-producing pancreatic beta cells, which is caused by the development of immune response directed to autoantigens of pancreatic islets. In advanced diabetes, the patient is completely dependent on exogenous insulin. Therefore, a medical team from Uppsala University Hospital has conducted a clinical trial on the application of autologous bone marrow mesenchymal stem cells (MSC) with the aim of inhibiting progression of diabetes.

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ISSCR publishes guidelines for stem cell science

The International Society for Stem Cell Research (ISSCR), an international organization that gathers scientists from the area of stem cells, is currently preparing a document, that will provide information on good practices in stem cell research and stem cells based experimental therapies. Draft of the document has been already posted on-line but now the organization it accepting comments from the scientific community before publishing the final version.

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Allogeneic Mesenchymal Stem Cells – safety and efficacy

Mesenchymal stem cells (MSC) isolated from bone marrow or adipose tissue are usually being used in clinical trials in an autologous settings, i.e. the patient receives his own cells. Intra-articular injections of autologous MSC were proved to be effective in the treatment of knee osteoarthritis. MSC isolated from the patient’s bone marrow or adipose tissue reduced pain 3 to 6 months after treatment when injected intra-articulary.

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Stem cells from adipose tissue are effective in anti-aging therapy

Scientists from the University of Verona and University of Rio de Janeiro applied an anti-aging skin treatment basing on autologous stem cells isolated from adipose tissue. The study involved application of two methods for preparation of cell suspension. In the first method, purified and expanded stem cells were used. The second method utilized fat enriched in so called stromal-vascular fraction, which contains several cell types.

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Czy należy ubezpieczyć nasze wyroby medyczne?

Nie jest to nowością, że sponsor i badacz w badaniu klinicznym są zobowiązani do posiadania ubezpieczenia od odpowiedzialności …

EUDAMED a informacje publiczne

Niedawno został opublikowany dokument który pokazuje w jaki sposób będzie realizowana polityka przejrzystości informacji …

MedTech Europe help for Clinical Evidence Requirements for CE certification under the in vitro Diagnostic Regulation in the European Union

The “Clinical Evidence Requirements for CE certification under the in vitro Diagnostic Regulation in the European Union” …