Brazil's national regulatory agency, Anvisa, has expedited the process for importing high-risk medical devices (Class III and IV) by agreeing to review devices as soon as its foreign manufacturing site is granted a Certificate of Good Manufacturing Practices (CBPF) by a foreign regulator.  Under the revised procedure (RDC 15/2014), new high tech devices should enter the Brazilian market sooner, since the analysis of the device by the agency can proceed while the ...

The US Food and Drug Administration (FDA) may have recently unveiled a new rule intended to facilitate more coherent responses to ongoing drug shortages, but some legislators are now hunting for answers about one shortage of a drug used to treat childhood cancer patients, saying neither the agency nor the drug's manufacturer have been able to provide answers thus far. Background As regular readers of Focus well know, drug shortages have been an endemic problem in the ...

Despite the US Food and Drug Administration's (FDA) ongoing efforts, the problem of drug shortages is persisting with a stubborn tenacity, particularly in several high-need areas. But with its existing method of alleviating drug shortages in legal jeopardy, FDA now seems to be adopting a more permanent tactic to confronting some shortages: full and expedited approvals. Background Drug shortages emerged as a major issue in 2011 and 2012, with many generic sterile injecta...

India's Central Drugs Standard Control Organization (CDSCO) has established procedures for the import of small quantity of drugs for personal use "for the needy patients of India." Generally, an individual can import a quantity not to exceed 100 "average doses" as long as the drug is part of the "bona fide" personal luggage of the individual and is declared to Customs.  However in "exceptional cases," an individual may import "a large quantity" for personal use ...

Have you ever opened your email to find a message that contained something like: "This CFG/CFS/CPP/COE 1,2,3,4 must be apostilled 5 for Russia"? "These ISO certs 6 need legalization (or consularization) from the Consulate of Brazil"? Either you are very familiar with these requirements or, particularly if your company is relatively new to foreign markets, you have no idea what these terms mean. It's important to know that when engaged in marketing its medical...

Indian pharmaceutical companies will now be required to inform the Central Drugs Standard Control Organization (CDSCO) about any drug import alert restrictions imposed on their products by foreign regulatory authorities, according to a new notice issued on 26 June 2013 by the Drugs Controlled General of India (DCGI). The notice highlights the fact that local manufacturers whose drugs are the subject of foreign regulatory action also supply the same or similar drugs on ...

On 2 July 2013, new rules are set to go into effect in the European Union that radically change the process by which active pharmaceutical ingredients (APIs) manufactured outside the EU enter into the region. And while many countries are scrambling to get basic systems into place that will allow the manufacturers they regulate to meet the rules, Japan has now joined a small but elite group of nations that will be able to bypass many of the rules' most onerous provisions. ...

The China Food and Drug Administration (CFDA) has issued a notice setting deadlines for implementing electronic monitoring for imported essential drugs. Imported drugs in domestic packaging must comply with electronic monitoring requirements by the end of November 2013, and all other imported drugs by the end of March 2014. The implementation of electronic monitoring is to be done in accordance with the former State Food and Drug Administration notice "on the issuance...

The European Heads of Medicines Agencies (HMA) has notified the European Commission of its "deep" concern that the implementation of the Falsified Medicines Directive (2011/62/EU) will lead to possible shortages of medicinal products with resulting risks to public health.   The Directive, which goes into effect on 2 July 2013, requires all imported active pharmaceutical ingredients (APIs) to be manufactured in compliance with the standards of good manufacturing pr...

Chinese authorities have announced that as of 1 April 2013, all text appearing on the outside labeling and packaging of imported medical devices must be in Chinese, according to a notice issued to provinces, autonomous regions and municipalities by China's State Food and Drug Administration (SFDA) on 24 September. The Chinese text version can be "attached" to the foreign language, though it is unclear what forms will be permitted. Any devices not in compliance with the r...

[Editor's note: the majority of Brazilian regulatory authorities ended their strike on Monday, 3 September 2012 according to Reuters . Approximately 10% of workers remain on strike.] The Brazilian press is claiming that the ongoing strike of employees at the country's National Health Surveillance Agency, Anvisa, is threatening to create drug shortages throughout the country.   "In the hospitals, concerns have grown over shortages of essential medicines an...

New import rules ( RDC 43 ) released by Brazilian regulatory authority Anvisa on 6 August clarify that products subject to regulation may obtain import approval if the import license application is not examined within five working days from the date of request by the importer.  The new rules cover situations where a labor strike-such as the one recently launched by many Anvisa regulators -or other event slows down the import administrative process or when th...