• Regulatory NewsRegulatory News

    Congress Takes First Look at User Fee Program for OTC Drugs

    The House Energy & Commerce committee on Wednesday held its first hearing on a bill to reform the US Food and Drug Administration's (FDA) over-the-counter (OTC) drug monograph process by creating a new user fee program and offering marketing exclusivity for innovations to monograph products. A bipartisan discuss draft of the bill, developed by Reps. Bob Latta (R-OH), Diana DeGette (D-CO), Brett Guthrie (R-KY), Debbie Dingell (D-MI), Gene Green (D-TX) and Subcommittee o...
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    Pfizer Proposes to Make Viagra Available in the UK Without a Prescription

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has released a Pfizer proposal calling to make the popular erectile dysfunction drug sildenafil (more commonly known as Viagra) available without a prescription at UK pharmacies. MHRA said it considers that “direct risks can be minimised to an acceptable level for Pharmacy supply of sildenafil 50mg tablets.” Other ways to minimize those risks include Pfizer’s proposal that the drug only be made availa...
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    FDA Considers New User Fee Program for OTC Drugs

    The US Food and Drug Administration (FDA) on Tuesday announced that it will gather information on creating a new user fee program for nonprescription, over-the-counter (OTC) drugs. User fee programs (such as PDUFA , GDUFA , BsUFA and MDUFA , all of which are now being re-negotiated for 2017) are the life blood of FDA and provide much-needed financial resources from industry, in addition to Congressional appropriations, that support the timely and efficient review of...
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    Taiwan Regulators in Push to Switch More Drugs to OTC Status

    The Taiwan Food and Drug Administration (TFDA) announced this month that it will be reclassifying 13 prescription drugs to be available over the counter (OTC), the Taipei Times reports. The move is part of a larger push in Taiwan to improve access to basic medicines and reduce healthcare spending. The regulator is planning for the reclassified products to be available for OTC sales in June 2015. Self-Medication TFDA said it is looking to reclassify as many pres...
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    UK's MHRA Puts New Restrictions on Popular Painkiller

    A widely used over-the-counter painkiller has been reclassified as a prescription-only medicine (POM) by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). In a press release on 14 January 2015, MHRA announced that patients will now need a prescription to purchase diclofenac oral tablets. The agency cited concerns over “increased risk of serious cardiac side effects in some patients,” which is worsened by long-term or high-dose use. The decision to re...
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    Ireland Considers Switching 12 Medicines to OTC Status

    Ireland's Health Products Regulatory Authority (HPRA) has published a list of twelve active ingredients (or combinations of ingredients) that are currently classified as prescription-only medicines (POM) which it believes could safely be made available to consumers over-the-counter (OTC). There are currently 34 drugs approved in Ireland that contain one of the ingredients included on the list, including medicines for the treatment of migraine, acid reflux, hay fever, ...
  • Australia and New Zealand Implement Harmonized OTC Regulatory System

    Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medsafe have announced that a new over-the-counter (OTC) drug process for the evaluation of new and changed OTC medicines will be implemented in each country as of 15 April 2013. Companies will have a one-year transition phase to become familiar with the new submission formats, during which time OTC products already marketed will remain on the market and sponsors of new OTC products will comply with ...
  • Brazilian Consumers Allowed to Purchase OTC Drug Products Under New Rules

    Brazilian consumers will not be able to purchase over-the-counter drug products at pharmacies according to new rules published 17 July 2012 by Brazilian health regulator Anvisa. Under the new rules, the OTC products may be purchased in a manner similar to cosmetics and dietary supplements,regulators explained. OTC drugs must be organized on pharmacy shelves by active ingredient with the cautionary statement that drugs may cause unwanted side effects.  Anvisa open...
  • Full Information From FDA OTC Switch Meeting Released

    The complete information from the 23 March over-the-counter switch meeting between the US Food and Drug Administration (FDA) and industry and public stakeholders has been made public. FDA is currently considering whether to create regulations that would make it easier for consumers to buy medications that are currently prescription-only. The so-called "over-the-counter (OTC) switch" would make some popular medications available OTC if they can be used safely with minimal...