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Asia Pacific

Set Alert for Asia Pacific

Latest From Asia Pacific

Zero Compliance With Indian GMP/GLP Self-Inspection Rule Prompts New DCGI Notice

The Drug Controller General of India has reissued its demand for manufacturers to comply with a new self-inspection and reporting rule and has set a deadline for them to do so.

India Manufacturing

Latest China Cybersecurity Proposal Could Impose Heightened Scrutiny On Biopharma

Drugmaking is among key information infrastructure industries likely subject to additional security and reporting obligations under draft legislation, adding costs and even potentially causing business disruptions, legal experts say.

Cybersecurity Legislation

Submit It Or Lose It: GMP Clearance Application Forms In Australia To Be Replaced

Drug makers working on applications for Australian GMP clearance for manufacturing steps conducted overseas are being advised to complete and submit their forms by Sept. 18, ahead of planned improvements.

Australia Manufacturing

Korea's Reimbursement Steps Spark Drug Price Cut Concerns

In its first announcement of major health care measures since the Moon Jae-in administration took charge, South Korea unveils steps to hike its national health insurance coverage ratio to levels in advanced countries, raising concerns that this might lead to sharp drug price cuts.

Policy Reimbursement

Dr. Reddy’s Under Fire From German Regulator; Has Risk Of Class Action Suit

Dr. Reddy’s compliance woes hit a new low, with the German regulator stopping supplies to the EU from the firm’s Bachupally unit over significant GMP deviations. Worse still, some foreign investor rights law firms appear to be pressing for a class action suit against the company.

Legal Issues Manufacturing

Saudi FDA Starts Bid For PIC/S Membership; Philippines Told To Reapply

Saudi Arabia has started the application process to join the Pharmaceutical Inspection Cooperation Scheme, while bids from Belarus, Chile, Brazil, Iran, Mexico, Turkey and other countries are wending their way through the PIC/S application procedure.

International Middle East and Africa
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Set Alert for Europe

Latest From Europe

More Questions As Biocon Pulls EU Filings For Two Biosimilars

Biocon and partner Mylan have withdrawn the European application for their biosimilar trastuzumab and pegfilgrastim in the backdrop of compliance blips at Biocon’s Indian site, raising critical questions on how soon things can be set right in an increasingly competitive scenario.

Biosimilars Manufacturing

Pharma Requests Pilot To Test Public Value Of EU Guide On Plain Language Summaries

The European pharmaceutical trade group EFPIA says an “initial pilot” program should be launched to test the value and impact of the draft EU guideline on presenting lay summaries of clinical trial results. The group believes that the guideline should be reviewed following the pilot, as complying with it in its current form would result in companies shelling out “significant additional resources.”

Clinical Trials Regulation

EU Member States Taking New Steps To Tackle Drug Shortages

The EU Heads of Medicines Agencies has outlined some of the recent initiatives taken by the member states to deal with medicines shortages, including a new Dutch center and a member state coordinating initiative by the Irish regulator.

Distribution Manufacturing

Updated EU Guideline On Manufacturing Finished Dosage Forms Addresses Supply Chain Complexities

New EU guidance will help companies preparing marketing authorization applications understand what to include in Module 3 of their common technical document.

Europe Manufacturing

Pharma Calls For Practical Advice On Using Risk-Based Approach To Trials in EU

The pharmaceutical industry and other stakeholders are calling for practical advice on how the new EU guideline on using a risk-proportionate approach to clinical trials will be implemented in practice. Clarity has been sought on several topics, especially on new requirements such as preparing a risk assessment and mitigation plan as part of a trial protocol.

Clinical Trials Safety

Medically Senseless: Why EU Pediatric Investigation Plans Should be Abandoned

Most clinical trials required under EU pediatric investigation plans are medically senseless, and many cause harm to patients, argues consultant Klaus Rose. This is a challenge not only for the pharmaceutical industry but for regulators and wider society as well.

Pediatrics Europe
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United States

Set Alert for United States

Latest From United States

Par Alleges 'Shocking' Trade Secret Theft By QuVa Pharma

Par says former employees who founded QuVa used Par's trade secrets to develop a vasopressin product, which FDA has added to its list of ingredients for drug compounding.

Intellectual Property Policy

Purdue's Butrans: US FDA Panel To Consider Pediatric Labeling, But Not A New Indication

Purdue says it conducted a trial required under the Pediatric Research Equity Act but is not seeking a formal indication and will not promote the opioid for pediatric populations. Two advisory committees will discuss the trial results and whether they support additional labeling for the buprenorphine transdermal product Sept. 13.

Advisory Committees Pediatrics

Consumer Health Weekly Trademark Review Aug. 8, 2017

Ccompiled from the Official Gazette of the US Patent and Trademark Office, Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) marks registered and published for opposition.

Consumer Trademarks

GMP Problems Stop Canadian Firms’ Topical OTC, Homeopathic Imports

Homeolab USA’s and Cellex-C’s imports were stopped earlier in 2017 following GMP inspections at their facilities, and FDA warns that approvals for marketing of additional products in the US could be withheld until each firm is GMP-complaint. Homeolab trips up by trying to prevent FDA photography inside plant.

Consumer Manufacturing

US FDA's China Staff Increase Takes Hold As Gottlieb Boosts Border Security

After receiving delayed visas, additional FDA is inspectors and other staff can relocate to China office; Gottlieb also announces increase in international mail facility staff.

Compliance Drug Safety

Breakthrough Requests Keep Climbing

Sponsors are seeking US “Breakthrough Therapy” Designations at a record pace in FY 2017.

Drug Review Regulation
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