Asia Regulatory Roundup: Japanese Regulators Receive Orphan Drug Training from EMA (6 October 2015)

Regulatory NewsRegulatory News | 06 October 2015 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Japanese Regulators Receive Orphan Drug Training from EMA

Staffers at Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) have received training on orphan medicines from the European Medicines Agency (EMA). The training session was led by Dr. Segundo Mariz, a member of EMA’s Committee for Orphan Medicinal Products (COMP).

Mariz has worked on the committee since 2009 and imparted some of the knowledge built up over this time to PMDA at the training event. In the session, titled “Orphan Medicine Designation and development in Rare Diseases,” Mariz detailed how COMP works with other parts of the European regulatory infrastructure and uses incentives to promote the development of treatments for rare diseases.

Japan first put special provisions in place for orphan drugs in 1985, at which time it was focused on accelerating review timelines and lowering data requirements for treatments for rare diseases. Only the United States has a longer history of regulating orphan drugs — the European Union only set up its legislative framework in 2000 — but with Japanese officials pushing to cut the time it takes to bring innovative medicines to patients, PMDA is clearly open to learning from other regulators.

Orphan drug legislation and accompanying guidelines have evolved throughout the 30 years in which they have been in place in Japan, although the core focus is unchanged. Recent amendments include the broadening of the definition of orphan diseases to include illnesses that affect fewer than 180,000 people in the country. Prior to the change, only drugs for diseases that affect fewer than 50,000 people in Japan were eligible for orphan status.

PMDA Newsletter

New Zealand Committee Finds No Link Between Gardasil and Autoimmune Diseases

New Zealand’s Medicines Adverse Reactions Committee (MARC) has found no link between Merck’s Gardasil vaccine and autoimmune diseases. MARC initiated the review of the literature after noting an overlap between the age at which the human papilloma virus (HPV) vaccine is administered and a common period for the onset of autoimmune diseases.

Having analyzed available observational studies and other resources, the panel unanimously agreed that there is no cause for concern about a link between Gardasil and autoimmune diseases. MARC’s confidence in the safety profile of Gardasil is the latest in a long line of votes of confidence for the much-discussed HPV vaccine. The panel also reviewed the coroner’s report on an 18-year-old girl who died six months after receiving her final dose of Gardasil. Cardiac arrhythmia is suspected.   

MARC used the meeting to discuss a potential link between statins and interstitial lung disease, too. The possible link was raised by a report to New Zealand’s Centre for Adverse Reactions Monitoring (CARM) about a patient on statins who showed symptoms of interstitial lung disease. MARC found a few other case reports in its literature review and as such has recommended the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) shares the information with physicians.

MARC Minutes

China Fines Fosun Pharma for Failing to Obtain Clearance for Acquisition

The Chinese Ministry of Commerce has ordered Fosun Pharma to pay a fine for failing to obtain the approval of the government before making an acquisition. Officials handed out the punishment after investigating the purchase of a stake in Suzhou Erye Pharma by a unit of Fosun Pharma.

Fosun Pharma entered into talks with the relevant officials regarding its acquisition of a 65% stake in Suzhou Erye Pharma but, according to the commerce ministry, it transferred 35% of the business before gaining government approval. State officials viewed the misstep as a breach of anti-monopoly laws and, following a review of the situation, have ordered Fosun Pharma to pay a fine of RMB 200,000 ($31,000).

The ministry sent the letter on 16 September and made it public two weeks later. If Fosun Pharma fails to pay the fine, the ministry could take further action against the company. For a company with a substantial amount of money and an acquisition-driven growth strategy — Bloomberg reports it has spent $1.6 billion on 17 deals since 2010 — the fine is relatively small, though.

Ministry Letter (Chinese), FiercePharmaAsia

TGA Proposes Relaxing Regulations on Availability of Heartburn Treatments

The Australian Therapeutic Goods Administration (TGA) has proposed relaxing regulations on the availability of certain treatments for heartburn. If the changes come into force, patients buying and taking the products would no longer require the advice and monitoring of a pharmacist.

Forms of lansoprazole, omeprazole and rabeprazole would be affected by the proposed changes. As it stands, 14-day packs of the heartburn products are classed by TGA as Schedule 3 drugs, provided they contain no more than 15mg, 20mg and 10mg per dosage unit, respectively. The plan is to add seven-day packs of the products to Schedule 2, a lower rank that removes the need for a pharmacist to be involved in the process.

TGA is seeking feedback on the proposal until 29 October. The regulator is particularly keen to hear whether people think all over-the-counter proton pump inhibitors — the class of products that includes lansoprazole, omeprazole and rabeprazole — should be in the same schedule. This is not currently the case. Seven-day packs of pantoprazole are already in Schedule 2, while esomeprazole, the active ingredient in Nexium, was only downgraded to Schedule 3 last year.

TGA Notice

Other News:

Allergan is recalling certain batches of its treatments for dry eyes in Australia. TGA is working with Allergan on the recall, which affects Ircal and Refresh Night Time eye ointments. Allergan began the action after receiving reports that small particles of black plastic are being transferred from the lid of the product to the ointment when the tube is opened. TGA Notice

Subrahmanyam Jaishankar, India’s foreign secretary, has called the European Union ban on 700 drugs tested by GVK Biosciences “unwarranted.” Jaishankar still sees the restrictions as a barrier to the progression of free trade talks. “It's our hope that this matter would be looked at fairly and sensibly and would hopefully not be an impediment to the free trade deal,” he said. Reuters

India is planning to introduce a mandatory marketing code for pharmaceutical companies. The Department of Pharmaceuticals (DoP) released a voluntary code in January but the government now has doubts about the effectiveness of this approach. “We found it very difficult to enforce it as a voluntary code,” DoP Secretary VK Subburaj said. Livemint

The Drug Controller General of India (DCGI) is set to propose amended manufacturing laws in the next six months. DCGI GN Singh thinks the changes are needed to bring India up to global standards. “We cannot live in isolation and will have to meet their expectations,” Singh said. The amendment process will entail analyzing the standards of Western regulators. Livemint   

Representatives of the All India Organisation of Chemists and Druggists (AIOCD) have called online drug sales “totally illegal” at a meeting of the committee set up to discuss regulation of the industry. AIOCD President Jagannath Shinde presented evidence to show online pharmacies will provide drugs to people without a prescription. The organization is still planning to strike. The Economic Times  

The Indian health ministry has followed through on committee recommendations to end the need to duplicate certain tests of drugs on animals. PharmaBiz


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