Life Science Compliance Update

September 19, 2017

Study Released on Comparison of International Regulatory Authorities



Pharmaceutical regulations vary widely across the world, and while our sister publication, Life Science Compliance Update, keeps compliance professionals abreast of new development and comparisons across continents and countries, an article published August 2017 in Nature Reviews Drug Discovery offers comparisons in terms of the regulators’ budgets, staff, new drug approvals and timelines for approvals.


Of the regulators in the more established major pharmaceutical markets (in this study, the United States, Europe and Japan are considered the regulators in such markets), the United States Food and Drug Administration (FDA) has the most internal reviewers (an estimated 2,000), though the European Medicines Agency (EMA) has a network of more than 4,500 experts providing scientific expertise to the agency.


Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), meanwhile, has about 560 reviewers, while the China Food and Drug Administration (CFDA) had only about 120 staff in its Center of Drug Evaluation to perform scientific evaluations through August 2015. Since August 2015, the research says the State Council of China has brought that number up to about 300 to work through a backlog of applications. 


As far as new drug application (NDA) submissions and approvals, differing NDA definitions or their equivalents between authorities make direct comparisons difficult, though in the established markets, the FDA was noted as approving the most NDAs for new drugs (45) in 2015, while Japan’s PMDA approved the most NDAs (48) in 2016. 


Similarly, timelines to NDA approval have different definitions and processes, though the researchers said the shortest time to market was 210 calendar days for EMA and the longest was 900 calendar days for CFDA (though CFDA is trying to accelerate that process). Several of the authorities also have programs to enable accelerated review of products that are considered to be addressing particularly important medical needs, such as the FDA's priority review designation, which is associated with a review timeline of 180 days, compared with the standard review timeline of 300 days.


NDA review fees also vary, the authors reported, noting India had the lowest fees (50,000 Indian rupees; ~$1,000), whereas FDA had the highest ($2.3 million). 


"Overall, the regulatory authorities in developed countries such as the United States, European Union, UK, Canada and Japan are more evolved in terms of regulatory systems and resources, such as technical reviewers, but have higher NDA fees," the authors wrote.




August 14, 2017

Sunshine Act Takes Effect in South Korea


In early 2017, South Korea joined the global transparency movement and enacted a “Sunshine Act” similar to others found around the world. The law requires pharmaceutical and medical device companies operating in South Korea to prepare an aggregated expenditure report if they have provided economic benefits to healthcare professionals and others employed at medical institutions during a fiscal year.

Interestingly, while the scope of the Korean Sunshine Act is broader than the United States law, it does not require companies to submit the aggregated report and any supporting documents to the government unless it is determined to be necessary by the Minister of the Ministry of Health and Welfare of Korea. Therefore, it follows that the collected data will not be made public.

The covered recipients for Korean Sunshine Act can be categorized into four groups: (1) pharmacists; (2) herbalists (including persons working for the relevant pharmacy); (3) “medical personnel”, which includes physicians, dentists, acupuncturists, midwives, nurses); and (4) medical institution founders (including the representative, director and other employees of a juristic person) or persons working for the relevant medical institution for the purpose of sales promotion, such as adoption of drugs or inducement of prescription.

Types of reportable economic benefits include:

  • Product samples;
  • Academic conference sponsorships;
  • Honorarium provided to a covered recipient for conducting post-marketing surveillance (PMS) (equivalent to phase 4 clinical trials in US);
  • Funding of clinical trials;
  • Food and beverages and other “freebies” (such as pens, notepads, etc.) provided at the product presentations; and
  • Discounts on drug or medical device sales made with certain payment methods.

The Ministry released seven templates for the Report for all reporting categories:

  • Provision of samples – including institution, product information, and date of provision;
  • Sponsorship to academic conferences – including conference info and support funds amount;
  • Support for clinical trials – including trial information, contact, joint investigator’s info, and support details (TOV amount, number/volume of product supported, contracting date);
  • Product presentations
  • Presentations held formultiple medical institutions: product info, HCP name and medical institution, TOV amount including travel, lodging, food and beverages, and other “souvenirs” or giveaways (e.g. pens, notepads, etc.)
  • Presentations held at a single medical institution: product info, medical institution info, HCP name, TOV amount (food and beverages) and date;
  • Post-market surveillances (PMS) – including product info, HCP info, and support details; and
  • Price discounts based on payment conditions – including medical institution info, contracting date, and discount rate

For the product presentations, the reporting threshold for food and beverages, as well as other “souvenirs” or giveaways is 10,000 won (roughly $9). For all other types of transfers of values, there is no minimum threshold amount triggering the reporting obligation, and they should all be recorded in the applicable reporting template.

The reports must be kept for five years, along with supporting documentation. Companies are required to start collecting expenditure information on January 31, 2018. The report and supporting documentation must then be prepared within three months following the end of the company’s 2018 fiscal year. For example, if Company A’s 2018 fiscal year ends December 2018, then the report must be prepared by March 2019. If Company B’s 2018 fiscal year ends in March 2019, then the report must be prepared by June 2019.

A reporting template was issued in June 2017, and can be found here. Life sciences companies operating in South Korea will need to create a clear and efficient process and system to ensure they meet these difficult reporting requirements.

Special thanks to Polaris a Quintiles-IMS Company for the tip and the analysis. and the Korean Ministry of Health and Welfare




August 09, 2017

EU Court Issues Over-Reaching Ruling on Vaccines


In June 2017, the Court of Justice of the European Union ruled that courts may consider vaccines to be the cause of an illness, even if there is no scientific evidence confirming a link. The Court said that if the development of a disease is timely to the person’s receiving a vaccine, it may serve as enough proof – provided that the person was previously healthy with a lack of history of the disease in their family and if a significant number of disease cases are reported among people receiving a particular vaccine.

The ruling stemmed from the case of a French man known as J.W., who was vaccinated against hepatitis B in 1998 and developed multiple sclerosis a year later. Multiple sclerosis is known to scar nerve tissue and cause a range of symptoms, from vision problems to paralysis. In 2006, J.W. sued pharmaceutical company Sanofi Pasteur, which produced the vaccine, blaming it for his decline in health. J.W. died in 2011.

The case was brought before the Court of Appeal in France, which ruled that there was no scientific consensus supporting a causal link and no evidence of a causal link between the hepatitis B vaccine and the man's multiple sclerosis, therefore dismissing the action. This judgment was appealed and brought to the French Court of Cessation, which took it to the European Court of Justice.

The Court of Justice said that "specific and consistent evidence" relating to timeliness, a prior healthy status, lack of family history and multiple cases may prove to be enough, according to a statement. J.W.'s case referred to the first three criteria.

While the court's decision is not a ruling on J.W.'s case, it is meant to provide guidance for all EU courts considering similar issues.

In a statement, a representative from Sanofi Pasteur said: "It is not our role to comment on this legal decision. However, Sanofi Pasteur wishes to reiterate that its vaccines are safe and effective and protect against infectious diseases. Our hepatitis B vaccines are safe and well tolerated. They have been approved by Health Authorities and are marketed for more than 30 years."

Expert Statements

"No causal link exists" between the hepatitis B vaccine and multiple sclerosis, "but a few cases after vaccination would not be surprising, especially when administered to teenagers, just before the age of onset age for many MS sufferers," said Keith Neal, emeritus professor in the epidemiology of infectious diseases at the University of Nottingham. "What they are saying is, the vaccine is responsible for the patient's MS if it can't be proved it isn't, and that is virtually impossible given what is worded. Potentially, this ruling affects all drugs and threatens the development of new drugs."

Peter Openshaw, president of the British Society for Immunology and professor of experimental medicine at Imperial College London, said, "it is very concerning that the European Court of Justice has ruled that judges can consider whether a vaccination led to someone developing a medical condition, even if there is no scientific evidence to support this."

"The scientific evidence does not support a link between the hepatitis B vaccine, or any other vaccine in current use, and multiple sclerosis," he said. "To say that there is a link between any vaccine and multiple sclerosis and at the same time to admit that there is no scientific evidence of such a link is illogical and confusing to the public."

"The only alleged evidence that would be worth taking seriously is the alleged numbers of other similar cases," he said. "Those data should be capable of detailed case comparisons for consistency, and probably also orthodox epidemiological study."

But without such a study, Fox added, "one might just as well say, 'If this vaccine causes MS, then why is it that millions of people have been vaccinated and did not get MS? And why are there so many people with MS who have never had this vaccination?' "


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