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The author reports on scientific methods of pharmaceutical production and quality assurance, and discusses research on it. He mentions a paper on the world of advanced therapy medicinal products (ATMP) which coincides with a paper published by the European Medicines Agency (EMA). He discusses the papers from Stephen McIndoe and Andrew Love on artwork control and from Peter Murray on the operating principles of aseptic manufacturing facilities.

An introduction is presented in which the editor discusses various reports within the issue including human error as a citation among companies as a cause of deviation with a subsequent corrective and preventive action, a review of the new European Medicines Agency (EMA) Draft Guideline on Sterilisation of the Medicinal Product and anti-counterfeiting and sterilisation issue.

Medicinal cannabis and respective products have been available in EU member states as single-patient prescriptions without regular marketing authorizations for a couple of years. The Netherlands was the first member state to realize this; in the meantime other member states have followed. Today, aside from the Netherlands, Germany is the most important market for such products. The regulatory framework for the approval of medicinal cannabis and its distribution to patients in the EU member states is, however, not harmonized at all, and there are distinct national regulations. Regarding the quality of such products, the general requirements for herbal medicinal products as defined in the European Pharmacopoeia, national pharmacopoeias, and the EMA guidance documents in place beside GMP requirements in the EU are applicable. However, for a couple of aspects, every EU member state follows its own interpretation of these requirements. To facilitate free distribution of such products between EU member states in future and to harmonize requirements for quality and GMP, an EU-wide approach is needed. As a first step, this should be realized by implementing monographs for cannabis medicinal products in the European Pharmacopoeia. [ABSTRACT FROM AUTHOR]

The article offers information on a concept paper about the introduction of fees to be charged by the European Medicines Agency (EMA) for pharmacovigilance activities, published by the European Commission on June 18, 2012.

The article explores efforts to regulate gene therapies by health authorities. Several of these health authorities are discussed including the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Additional topics discussed include the small number of deaths attributed to gene therapy, the first trials of gene editing inside the body, and how the EMA and FDA both use data-driven approaches to assessing drug safety and advocacy.

A report from the Institute for Scientific Freedom in Copenhagen, Denmark discusses their efforts to retrieve conflicts of interest declarations from the European Medicines Agency (EMA) over a period of three years. The researchers submitted Freedom of Information requests to access EMA's lists of committee members involved in drafting guidelines for psychiatric indications. After almost three years, the EMA provided member lists and conflicts of interest declarations from the Committee for Medicinal Products for Human use (CHMP) for three requested guidelines. The report recommends that the EMA improve transparency by publishing author names and conflicts of interest declarations directly in the guidelines. [Extracted from the article]

The article highlights the companies included in the Change the World list of "Fortune" magazine for 2015. They include telecommunications companies Vodafone and Safaricom, Internet giant Google and retailer Walmart. Vodafone and Safaricom created the mobile-money platform M-Pesa, which is said to have transformed the regional economy in Kenya. Google's commitment to fostering academic collaboration through its services such as Google Scholar, and Walmart's focus on sustainability are tackled.

A table is presented that summarises the status of all the parts of set of updated ISO 14644 series of standards for cleanrooms and associated clean environments including classification of air cleanliness, test methods and biocontamination control. It also mentions a concept paper issued by European Medicines Agency recommending the revision of the Annexure 1 of the European Union (EU) Good Manufacturing Practices (GMP) Guidelines on the manufacturing of sterile products.

The Regional Bank note of the Year Awards, part of the High Security Printing EMEA Conference recently held in Malta, have been conferred on winners in three categories: best new series; best new bank note; and best new commemorative bank... [ABSTRACT FROM AUTHOR]

The article reports that the European Union and Canada have agreed to exchange confidential information about the authorization and safety of medicines. The agreement was signed between the European Commission, the European Medicines Agency (EMEA), and the Health Products and Food Branch of Health Canada. The deal is expected to accelerate access to innovative drugs and improve performance and safety of drugs. Examples of information that can be exchanged are position papers on future legislation and scientific advice on product development.

The article investigates the risks with drugs that are being rushed to market after limited testing. Topics covered are the approval of drugs based on preliminary findings, international ramifications of approvals made by the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA), FDA's accelerated approval for bimatorpost for eyelash growth, EMA's granting of conditional marketing authorization to new drugs and expedited approval of cancer drugs.

The article discusses the development in the regulations in the pharmaceutical industry. It talks about the European Medicines Agency's (EMA) mission to protect human and animal health, and also ensure safe access to quality medicines. It states that implementation of Good Manufacturing Practice (GMP) has to be ensured. It is noted that the U.S. Food and Drug Administration (FDA) is amending its regulations on drug establishment registration and listing.

The article offers information on developments in the regulations of the pharmaceutical industry. Topics discussed include the European Medicines Agency starting to review the guidelines that describe first-in-human clinical trials and the data needed to enable their appropriate design and allow initiation, the EU Good Manufactuing Practices needed for sterilisation processes of primary packaging and introduction and implementation of safety features on packaging.

The article discusses developments in the regulations of the pharmaceutical industry worldwide. It mentions that the European Union has issued several guidelines including the guideline on process validation for the manufacture of biotechnology-derived active substances by European Medicines Agency (EMA). It states several guidelines for pharmaceutical industry issued by the U.S. including Interpreting Sameness of Monoclonal Antibody Products under the orphan drug regulations.

The article reports that the European Medicine Agency (EMA) has advanced its database "EudraGMP" as "EudraGMDP." It reports that EudraGMDP contains information on various subjects including good distribution practice (GDP) certificates, wholesale distribution authorizations and statements of non-compliance with GDP. It focuses on several modified rules in European pharmaceutical industry such as water for injection (WFI), marketing authorization variations and herbal drugs.

Novavax hit another roadblock in its COVID-19 vaccine journey in the U.S., with the company pushing back an FDA filing from May to July to now the fourth quarter. The company filed in India, Indonesia and the Philippines this week, and expects more submissions later this year with WHO, UK, EU, Australia, Canada and New Zealand. [ABSTRACT FROM AUTHOR]

The article informs that the Marketing Authorization Application from Pfizer Inc. has been accepted by the European Medicines Agency for bazedoxifene/conjugated estrogens. It mentions that the medicine is used for the treatment of osteoporosis and estrogen deficiencysymptoms in postmenopausal women. It further informs that the medicine has been developed by Wyeth which has been later acquired by Pfizer.

The article informs that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has adopted a positive opinion to grant orphan drug designation to the company ERYTECH Pharma's investigational product ENHOXY for sickle cell disease. ENHOXY enhances the oxygenation properties of red blood cells by reducing their oxygen-hemoglobin affinity and allowing them to release more oxygen.

The European Medicines Agency management board has nominated Emer Cook to be the next executive director of the agency. Cooke, who works at the World Health Organization, will replace Guido Rasi later in the year if she comes through the remaining steps in the hiring process. [ABSTRACT FROM AUTHOR]

The article reports the approval of the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for using pharmaceutical company Gedeon Richter's Esmya tablets for the treatment of uterine fibroids.

This section offers news briefs related to pharmacovigilance. A public Web site was launched by the European Medicines Agency (EMA) for adverse drug reaction reporting. Reforms have been planned by the Australian Therapeutic Goods Administration (TGA) for the regulation of complementary medicines. The Medicines and Healthcare Products Regulatory Agency (MHRA) considers the risk of keratitis as a class effect for epidermal growth factor receptor (EGFR) inhibitors.

The article reports on the decision of the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) to review the benefits and risks of the fixed combination of modified-release niacin + laropiprant, after the failure of a large trial funded by Merck, Sharp & Dohme (MSD).

The article reports on guidance issued by the European Medicines Agency (EMA) in 2012 for the format and content of non-interventional post-authorisation safety study (PASS) protocols.

The article reports on the adverse reactions research priorities for 2013 announced by the European Medicines Agency (EMA), including the long-term safety of antipsychotics in patients with dementia and the long-term adverse skeletal effects of bisphosphonates.