The main RAPS website will offline for several minutes at 5 PM on 22 October 2021 due to scheduled maintenance.
We apologize for any inconvenience during this time.

  • Feature ArticlesFeature Articles

    Quality Certificates for Small Molecule Drug Product Applications for International Regulatory Submissions

    This article provides a global overview of the general requirements and issues regulatory professionals may encounter while arranging for a variety of certificates for applications for small molecule drug products to be marketed internationally in the EU, US, Canada, Australia and Japan. Introduction From clinical trials to marketing authorization, regulatory dossiers for small molecule drug products are incomplete without the presentation of certain regulatory certif...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA Issues Increasing Number of GMP Non-Compliance Statements in India (11 May 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EU GMP Inspectors Issued Non-Compliance Statements to 11% of Indian Sites Visited in 2016 Authorities in the European Economic Area (EEA) issued non-compliance statements to 11% of the Indian drug manufacturing plants they inspected in 2016. The rate of non-compliance is far higher than the 1% recorded globally in 2016 and the 4-6% level seen in India in the three prev...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: Australia Scraps Target Date for Processing GMP Applications (25 April 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Scraps 15-day Target for Processing GMP Clearance Applications Australia’s Therapeutic Goods Administration (TGA) has scrapped its 15-day target timeframe for processing good manufacturing practice (GMP) clearance filings. The target is a long-standing part of TGA’s guidelines for overseas manufacturers, but has become progressively harder to achieve as the volum...
  • Regulatory NewsRegulatory News

    MHRA Investigates GMP Deficiency Trends From 2016

    The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Tuesday released a new report on the trends seen from inspecting pharmaceutical manufacturing plants and evaluating their good manufacturing practices (GMPs) in 2016. Compared to 2015, MHRA conducted 21 more total GMP inspections in 2016, and three more foreign inspections. But like in 2015, the most cited deficiency for 2016 was related to companies’ quality systems. Sterility assurance, producti...
  • Regulatory NewsRegulatory News

    Pharmaceutical Inspection Co-operation Scheme Offers New Strategic Plan Through 2019

    The Pharmaceutical Inspection Co-operation Scheme (PIC/S) this week unveiled a new road map for the next two years during its February meeting in Switzerland, which was attended by representatives of 37 of its regulatory authorities. Training was cited as PIC/S’ “most important field of activity,” and following the July 2016 launch of the PIC/S Inspectorates’ Academy (PIA), the group says considerations will be made on training inspectors on the revised Annex 1 on steril...
  • Regulatory NewsRegulatory News

    US and EU Forge Landmark Agreement to Mutually Recognize Drug Manufacturing Inspections

    After wrangling over the details of trade secrets and inspection differences, the US and EU on Thursday finally announced they have agreed to mutually recognize one another’s pharmaceutical manufacturing inspections – a deal likely to lead to less duplicative inspections and lower costs on both sides of the Atlantic. Originally part of the Transatlantic Trade and Investment Partnership discussions under President Barack Obama , the agreement will allow US and EU regulat...
  • Regulatory NewsRegulatory News

    Updated: TTIP on Thin Ice Not Likely to Delay US-EU Mutual GMP Recognition Deal

    A deal to further harmonize and mutually recognize good manufacturing practice (GMP) inspections between the US and EU will not be delayed, as the EU ambassador to the US said Wednesday that the Transatlantic Trade and Investment Partnership (TTIP) is in a state of pause as there is no one within President Donald Trump’s administration with whom to continue discussions. Despite the TTIP pause, a spokesman from the EU ambassador told Focus  via email on Thursday evening ...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: India Asks China to Expedite GMP Inspection to Resolve a Drug Shortage (14 February 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Asks China to Expedite GMP Inspections, Resolving Essential Medicine Shortage India has resolved the shortage of a rare disease drug after asking China to expedite the inspection of a manufacturer of active pharmaceutical ingredients (APIs). The Drug Controller General of India (DCGI) made the cross-border intervention to accelerate the resumption of API supply ...
  • European Regulatory Roundup: UK Fines Pfizer for 2,600% Price Hike (8 December 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EC Appeases Some SMEs With Revised Advanced Therapy GMPs but Objections Remain The European Commission has received some favorable feedback on its draft good manufacturing practice (GMPs) guidelines for advanced therapy medicinal products (ATMPs). However, while small and medium-sized enterprises (SMEs) were broadly supportive of changes proposed in the draft, the commission...
  • Regulatory NewsRegulatory News

    FDA Warns Spanish API Maker for GMP Violations

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Spanish active pharmaceutical ingredient (API) maker Interquim, S.A. for several good manufacturing practices (GMP) violations uncovered during an inspection of the company's Barcelona facility last May. In a warning letter, FDA cites Interquim for three issues related to its cleaning procedures, deteriorated equipment surfaces and stability testing data. According to FDA, Interquim d...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Shifts to Random Inspections (6 December 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. DTAB Proposes Stipulations to Indian Plan for Permanent Licenses The Indian Drugs Technical Advisory Board (DTAB) has given its conditional support to end the need to renew licenses to make, sell and test drugs. DTAB is broadly in favor of the idea, but has suggested stipulations that are more burdensome than those proposed by the Drug Controller General of India (DCG...
  • Regulatory NewsRegulatory News

    US, EU Look to Mutually Recognize GMP Inspections by January 2017

    The US and EU say they have made more progress on harmonizing good manufacturing practice (GMP) inspections and could reach a deal by January 2017, according to a report on the 15th round of negotiations for the Transatlantic Trade and Investment Partnership (TTIP). Progress on mutually recognizing GMP inspection has been ongoing since June , particularly as the US Food and Drug Administration (FDA) has observed at least eight audits since 2014 and as six additional aud...