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Filtering on: "geography middle east"

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WHO to Craft Essential Diagnostics List By Zachary Brennan - Published 16 June 2017

The World Health Organization (WHO) has received a recommendation from an expert committee to develop an Essential Diagnostics List (EDL).

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, Oceania, WHO, Due Diligence, Government affairs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: WHO essential diagnostics, EDL, Essential medicines list

Challenges Providing Pharmaceutical Products to Syrian Refugees By Zeina Sahloul - Published 24 May 2017

This article discusses the difficulties encountered by medical personnel working with refugees in Syria and delivering pharmaceutical products. It describes relevant regulatory policy and guidance for drug procurement and quality.

Categories: Features, Middle East, WHO, Crisis management, Drugs, Submission and registration

Tags: Syrian Refugee Crisis, Prequalification, UNHCR, Essential Medicines, MSF

Regulatory Harmonization Initiatives By Mukesh Kumar, RAC, Eliane Barras, MSc, Lewis Lau, RAC - Published 09 May 2017

This article provides an overview of global regulatory harmonization initiatives and addresses how various regulatory and other organizations are working toward improving access to medicinal products, such as pharmaceuticals and medical devices, and increasing quality through internationally harmonized inspection standards.

Categories: Features, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, Oceania, US, APEC, GHTF, ICH, IMDRF, ISO, OECD, WHO, Biologics and biotechnology, Compliance, Drugs, Medical Devices

Tags: Harmonization

US Trade Report Highlights Pharma's IP, Counterfeit Issues Abroad By Zachary Brennan - Published 01 May 2017

The Office of the United States Trade Representative's (USTR) 2017 report on the state of intellectual property (IP) protection and enforcement in US trading partners around the world offers a look into concerns regarding market access barriers, particularly for those in the pharmaceutical and medical device industries.

Categories: News, Asia, Europe, Middle East, US, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: US Trade Representative, IP protection, pharmaceutical IP, drug counterfeits

ICH Offers Updates on New Members, Progress on Guidelines By Zachary Brennan - Published 08 February 2017

The International Council on Harmonisation (ICH) has added new observers and members, as well as updates on different guidance documents discussed at its November meeting in Japan, according to meeting minutes released Wednesday.

Categories: News, Asia, Canada, Europe, Latin America and Caribbean, Middle East, US, ICH, Biologics and biotechnology, Compliance, Drugs, Quality, Regulatory intelligence, Regulatory strategy

Tags: ANVISA, BIO, MFDS, CECMED, MCC, S11, GCP, regulatory guidance

EMA Explains How it Supports Article 58 Applications By Michael Mezher - Published 07 February 2017

The European Medicines Agency (EMA) on Tuesday released a document discussing the regulatory support available to drugmakers looking to submit applications via the Article 58 procedure in an attempt to increase access to medicines in low- and middle-income countries (LMICs).

Categories: News, Africa, Asia, Europe, Latin America and Caribbean, Middle East, EMA, WHO, Biologics and biotechnology, Drugs, Regulatory strategy

Tags: Article 58, Scientific Advice, Business Pipeline Meeting

WHO Prequalifies First Hepatitis C Diagnostic By Zachary Brennan - Published 05 December 2016

The World Health Organization (WHO) on Monday announced it has prequalified its first hepatitis C virus (HCV) rapid diagnostic test, which will help diagnose HCV in low- and middle-income countries and potentially improve access to treatment.

Categories: News, Africa, Asia, Europe, Latin America and Caribbean, Middle East, WHO, Government affairs, In vitro diagnostics, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: WHO, prequalification, Gilead, Hepatitis C

Regulatory Recon: CRISPR Gene Editing Tested in First Person; Republicans Tell US Federal Agencies to Stop Work on Regulations Until Trump Takes Office (16 November 2016) By Zachary Brennan - Published 16 November 2016

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, Oceania, US, DOJ, EMA, FDA, FTC, MHRA, NICE, PMDA, TGA, Biologics and biotechnology, Business and Leadership, Clinical, Drugs, Government affairs, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Four Pharma Companies Lead in Regulatory, Legal Compliance By Zachary Brennan - Published 14 November 2016

Gilead, Novo Nordisk, Eisai and AbbVie have been singled out as the only companies that were not found by a court or regulator over the past two years to have breached criminal or civil laws or codes of conduct related to corruption or unethical marketing, according to the 2016 edition of the Bill & Melinda Gates Foundation’s Access to Medicines Index.

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, US, ICH, WHO, Biologics and biotechnology, Drugs

Tags: pharmacovigilance, pharmaceutical regulatory compliance, Gilead, Sanofi, Takeda, Pfizer, Novartis, Takeda, Gates Foundation, pharma regulations

WHO to Add $20m in Industry Fees to Keep Prequalification Program Sustainable By Zachary Brennan - Published 30 September 2016

The World Health Organization (WHO), industry groups and other partners on Friday announced a new financing arrangement that will add $20 million annually in new industry fees to ensure the financial sustainability and quality of WHO’s prequalification program.

Categories: News, Africa, Asia, Europe, Latin America and Caribbean, Middle East, WHO, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy, Reimbursement, Submission and registration

Tags: WHO, prequalification of vaccines, prequalification of medicines, WHO funds

Long-Awaited UN Report Calls for Breaking Link Between Drug R&D Costs and Prices By Zachary Brennan - Published 14 September 2016

The United Nations (UN) High-Level Panel on Access to Medicines released its long-awaited report on Wednesday with recommendations sure to rile up the pharmaceutical industry as it calls for World Trade Organization (WTO) members to no longer link the cost of research and development (R&D) with drug prices, as well as for an increase in the issuance of compulsory licenses and to require the disclosure of pharmaceutical R&D costs.

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, US, WHO, Clinical, Distribution, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: UN High-Level Panel on Access to Medicines, UN reports on pharmaceuticals, compulsory licenses, pharmaceutical R&D

Medical Food & Food for Special Medical Purposes: Global Regulatory Challenges and Opportunities By Manfred Ruthsatz, PhD, Timothy Morck, PhD - Published 01 September 2016

This article addresses current worldwide regulatory challenges and practical opportunities for medical food/Food for Special Medical Purpose (FSMP) to improve the role of nutrition in support of optimal care for patients. It presents the regulatory framework governing this specific category in the US, EU and other parts of the world.

Categories: News, Africa, China, India, Japan, Canada, Europe, Middle East, Oceania, US, FDA, Nutritional and dietary supplements

Tags: Medical Food, Food for Special Medical Purposes

Novartis Subsidiary Pays $16m to Settle Charges of Illegally Shipping Drugs and Devices to Iran, Syria and Sudan By Zachary Brennan - Published 29 August 2016

Novartis subsidiary Alcon Laboratories has agreed to pay more than $16 million to settle allegations of manufacturing drugs and medical devices in the US and then shipping them to Iran, Syria and Sudan despite US trade embargoes that prohibit such sales.

Categories: News, Africa, Middle East, Distribution, Due Diligence, Government affairs, Medical Devices

Tags: Alcon Labs, Novartis, Iran, Syria, Sudan

Data Integrity: New Draft Guidance and Q&A By Zachary Brennan - Published 11 August 2016

The European Medicines Agency (EMA) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) on Thursday released new draft guidance and a question and answer document to help ensure that data integrity is maintained during the process of testing, manufacturing, packaging, distributing and monitoring medicines.

Categories: News, Africa, Asia, Canada, Europe, Middle East, Oceania, US, EMA, FDA, Active pharmaceutical ingredients, Business Skills, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: PIC/S, data integrity of medicines during manufacturing, pharmaceutical manufacturing, GMP drug manufacturing

US Generics Firm Reports Counterfeit Cancer Drug Sales in Three Countries By Zachary Brennan - Published 12 May 2016

New Jersey-based generic drugmaker Heritage Pharmaceuticals last week announced that counterfeit drugs labeled the same as its 100mg chemotherapy BiCNU (carmustine for injection) have been sold and distributed in India, Ireland and Israel.

Categories: News, Asia, Europe, Middle East, US, FDA, Biologics and biotechnology, Crisis management, Government affairs

Tags: generic cancer drugs, Heritage Pharmaceuticals

USTR: 97% of Counterfeit Drugs in US Shipped From Four Countries By Zachary Brennan - Published 02 May 2016

The Office of the US Trade Representative (USTR) is raising new questions in its latest special report about some trade partners’ practices of limiting imports of foreign pharmaceutical and medical devices, as well as major concerns about counterfeit drugs and devices coming from four Asian countries.

Categories: News, Asia, Europe, Middle East, US, Biologics and biotechnology, Compliance, Distribution, Drugs

Tags: US trade representative, counterfeit drugs, Indian drug counterfeits, US trade partners for pharmaceuticals

USTR: 97% of Counterfeit Drugs in US Shipped From Four Countries By Zachary Brennan - Published 02 May 2016

The Office of the US Trade Representative (USTR) is raising new questions in its latest special report about some trade partners’ practices of limiting imports of foreign pharmaceutical and medical devices, as well as major concerns about counterfeit drugs and devices coming from four Asian countries.

Categories: News, Asia, Europe, Latin America and Caribbean, Middle East, Oceania, US, Biologics and biotechnology, Compliance, Crisis management, Drugs, Government affairs

Tags: US trade representative, counterfeit drugs, Indian drug counterfeits, US trade partners for pharmaceuticals

Article 58: How EMA Helps Increase Access to Drugs in Low- and Middle-Income Countries By Zachary Brennan - Published 26 April 2016

Ten years into the European Medicines Agency’s (EMA) regulatory experiment to try to increase access to medicines in low- and middle-income countries (LMICs) and the agency is seeing limited success, though enhancements outlined in a new report could increase the utility of the program.

Categories: News, Africa, Asia, Europe, Middle East, Oceania, EC, EMA, WHO, Biologics and biotechnology, Distribution, Drugs, Ethics, Government affairs, Preclinical, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Article 58, LMIC medicines, vaccines, tuberculosis, drug approvals, NRAs

Regulatory Recon: FDA Approves New Renal Cell Carcinoma Drug; Reduced ANVISA Fees for Some Due to Lawsuit (26 April 2016) By Zachary Brennan - Published 26 April 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Asia, Canada, Europe, Middle East, US, Anvisa, CDSCO, EC, EMA, FDA, Health Canada, IMDRF, MHRA, Biologics and biotechnology, Clinical, Crisis management, Drugs, Government affairs, Labeling, Manufacturing

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Recon: New FDA Guidance on Assay Development and Validation; Battle Over Drug Pricing Hits Germany (25 April 2016) By Zachary Brennan - Published 25 April 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Asia, Canada, Europe, Middle East, US, EC, EMA, FDA, Health Canada, MHRA, PMDA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Manufacturing, Medical Devices, Quality

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Coalition Calls on FDA to Follow EMA’s Lead and Offer Scientific Opinions on Use of Drugs Outside US By Zachary Brennan - Published 21 April 2016

As part of efforts to streamline and strengthen regulatory pathways for global health products, the Global Health Technologies Coalition (GHTC) says in a new report issued Thursday that Congress should direct the US Food and Drug Administration (FDA) to establish a specific mechanism to offer a formal scientific opinion on medical products for their use outside the US.

Categories: News, Africa, Asia, Europe, Latin America and Caribbean, Middle East, US, EMA, FDA, WHO, Biologics and biotechnology, Crisis management, Drugs, Due Diligence, Government affairs, Manufacturing, Medical Devices

Tags: Global Health Technologies Coalition, FDA scientific opinions, FDA task force, priority review voucher

FDA Warns Wearable Exoskeleton Manufacturer Over Post-Market Surveillance Failures By Zachary Brennan - Published 01 March 2016

Israel-based Argo Medical Technologies has been warned by the US Food and Drug Administration (FDA) after its failure to conduct post-market surveillance studies for its ReWalk device, which is meant to help individuals with spinal cord injuries to stand upright, walk, turn, and climb and descend stairs.

Categories: News, Middle East, US, CDRH, Crisis management, Due Diligence, Manufacturing, Medical Devices, Postmarket surveillance, Quality

Tags: Argo Medical, ReWalk Robotics, FDA warning letter, 522 Order

Importers of FDA-Regulated Products Prepare for February Shift to Automated System By Zachary Brennan - Published 09 December 2015

In partnership with Customs and Border Protection (CBP) and 46 other government agencies, the Food and Drug Administration (FDA) has developed and is quickly transitioning to a new portal through which industry can electronically submit all data required by government agencies for international trade.

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, Oceania, US, FDA, Active pharmaceutical ingredients, Audit, Biologics and biotechnology, Combination products, Distribution, Drugs, Government affairs, Medical Devices, Orphan products, Quality

Tags: FDA imports, import alert, ACE, CBP

WHO Calls for New Antivenom Treatments as Supplies Dwindle By Zachary Brennan - Published 04 December 2015

The World Health Organization (WHO) on Friday announced it's actively searching for new snake bite treatments as supplies of the most effective antivenom treatment are due to run out in 2016. Companies can now apply, with no submission fees, to have new treatments assessed by WHO beginning in March.

Categories: News, Africa, Asia, Middle East, US, WHO, Biologics and biotechnology, Clinical, Drugs, Government affairs, Manufacturing, Regulatory intelligence

Tags: WHO, anti-venom, snake bite cures, MSF

Regulatory Recon: US Pays More for Drugs as Lawmakers Take Personal Stake in Biotech, Device Companies (1 December 2015) By Zachary Brennan - Published 01 December 2015

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher , @Zachary Brennan and @RAPSorg on Twitter.

Categories: News, Asia, Europe, Middle East, US, CFDA, EMA, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Clinical, Drugs, Government affairs, Manufacturing, Medical Devices, Postmarket surveillance, Preclinical, Quality, Regulatory intelligence, Regulatory strategy

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News